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CRN Project Portfolio and Database

With a cadre of experienced scientists, representing a variety of disciplines, the CRN is able to apply diverse expertise across the spectrum of cancer control. The integrated nature of the health plans facilitates studies at the patient, provider and organization level. Descriptions of select CRN studies conducted in these various domains are found in the sections below.

The Project Database below includes core CRN projects, i.e., those that were funded as part of the CRN grant during the first three funding cycles (CRN1-CRN3*), either as a core research project, or through administrative supplements. Select CRN Pilot and Developmental Projects and CRN-related projects – those that take advantage of CRN infrastructure – funded under the Core grant are also included. The list is not exhaustive and does not include projects that have been facilitated by the CRN under its current funding mechanism (CRN4**).

Cancer Research Network funding cycles:
*CRN1 (07/01/1999 - 2/28/2003), Grant Number: U19 CA079689
*CRN2 (3/1/2003 - 4/30/2007), Grant Number: U19 CA079689
*CRN3 (5/1/2007 - 4/30/2012), Grant Number: U19 CA079689
**CRN4 (9/25/2012 - 8/31/2017), Grant Number: U24 CA171524

The list of projects is sorted by date with the most recent first. You can narrow this list using the dropdown menus below. Use the + button to show or hide the full project descriptions.

Show only projects matching these criteria:

Showing 106 projects.minus sign Hide all descriptions

Diffusion of Community-based Radiation Oncology Direct link to this project

Project Staff:
  • Project Leader: Elizabeth Loggers, Group Health
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Maureen Rosetti, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2011

Area(s) of Research: Dissemination & Diffusion; Epidemiology & Surveillance; Health Services

Tumor Site(s): All

Phase(s) of Care: Treatment

Description: minus sign Hide

In 2010, 1.5 million people are expected to be diagnosed with cancer. Two-thirds of these individuals will receive radiation as part of their cancer treatment, either curative or palliative in intent. Given this, ensuring each cancer patient receives high quality radiation oncology care is critically important to improve cancer outcomes, reduce morbidity, and optimize the survivorship period. Despite radiation oncology’s importance, to date, the majority of information on the quality of radiation oncology care in America comes from two sources: clinical trials in radiation oncology care and the Quality Research in Radiation Oncology (QRRO) study.

The latter is an annual, voluntary, non-audited study of the quality and practice patterns of a national, randomized sample of radiation oncologists from all practice settings. The study began in the 1970s as a Patterns of Care Study conducted by the American College of Radiology. While ahead of its time in terms of quality measurement and oncology professional participation, the bulk of the current quality measures address conventional external beam radiation, with little attention placed on newer, high-cost, high-technology radiation methodologies, such as image-guided radiation therapy, or I.G.R.T., and intensity-modulated radiation therapy, or I.M.R.T, stereotactic radiosurgery (SRS), gamma or cyber knife and partial breast irradiation. This limitation is important due to growing concerns regarding the use of these new technologies without proper comparative data regarding outcomes, morbidity and cost-effectiveness and a lack of adoption of proven standard therapies. These concerns have been heightened by recent reports in the New York Times suggesting a lack of regulatory oversight or proper training, leading to numerous errors resulting in disfiguring injuries and death. In response, regulators, radiation oncologists, advocates, patients and families have called for greater oversight.

Given the critical importance of radiation oncology, its growing complexity and the increasing need to assure high quality care for cancer patients, the Specific Aims of this pilot study are to:

  1. Investigate capture and quality of radiation oncology data at three Cancer Research Network (CRN) sites (Group Health, Kaiser Colorado, Kaiser Northwest) between 2000-2008.
  2. Study the diffusion of radiation oncology facilities, equipment and services from 2000 to 2010.
  3. Build elements of radiation oncology data into the CRN Virtual Data Warehouse (VDW) for the three study sites, with methods and documentation for possible inclusion of radiation oncology data from all other CRN sites.

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Friend to Friend: Colorectal Cancer Screening Discussions Among Members of Social Networks Direct link to this project

Project Staff:
  • Project Leader: Sarah Cutrona, Meyers Primary Care Institute
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Kathleen Mazor, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2011

Area(s) of Research: Communication; Health Literacy; Behavior

Tumor Site(s): Colorectal

Phase(s) of Care: Screening

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Colorectal cancer is a significant cause of cancer morbidity and mortality in the United States, but available screening methods continue to be underutilized. Interventions aimed at increasing cancer screening rates find that peer support can be effective at overcoming barriers, possibly because peer-workers establish screening as a normative behavior. Friend-to-friend discussion, either verbal or electronic, is a common way for community members to provide each other with support and to establish expectations regarding normative behavior.

While findings from peer-worker studies are promising, relatively few studies have focused on peer interventions that use friend-to-friend communication to improve cancer screening. This is surprising, as adults over age 50 turn frequently to family and friends for information on colorectal cancer screening and subjective norms established by a friend or a family group are strongly associated with adherence to colorectal cancer screening. With over half of adults in this age group using email on a daily basis, some of these discussions may be taking place electronically. By avoiding face-to-face discussions on what can be a difficult topic, this mode of communication could facilitate communication around colorectal cancer screening.

Given the need to increase colorectal cancer screening, the importance of peer support, and the ever-increasing use of electronic communication, this is an ideal time to explore the feasibility and acceptability of electronic cancer screening message transmission between members of a social network. As a first step, it will be essential to learn more about existing practices surrounding friend-to-friend communication on colorectal cancer screening.

To this end, we propose a pilot study with the following specific aims:

Aim 1. To describe current practices in friend-to-friend and within-family discussions of colorectal cancer screening. We will interview 80 participants from the Fallon Community Health Plan (which uses colonoscopy as a standard screening approach) and25 participants from each of 2 additional CRN sites (where FOBT is most common) (130 total). All three sites are already participating in the CRN Health Literacy and Cancer Prevention project.. Interviews will focus on the extent to which participants communicate with members of their social network about colorectal cancer screening, collecting information on both the content and the mode of these discussions (e.g., in person, email, social networking sites, etc. Aim 2. To identify potential barriers to communication about colorectal cancer screening in friend-to-friend and within-family networks. Participants will be interviewed about barriers preventing them from discussing colorectal cancer screening with friends or family members.

Aim 3. To determine participant’s preferences for (1) message content and (2) mode of transmission (e.g. in person, email, social networking sites, etc) when discussing colorectal cancer screening. After studying how participants discuss screening and why they may avoid such discussions, we will seek participants’ guidance in the creation of messages that they would find acceptable for passing along to friends or family. Participants will be given a sample message about colorectal cancer screening, written from the perspective of a close friend or relative who has just completed screening. The message will refer to the sender’s personal experience as well as to key facts about screening. Participants will be asked to react to the message and to suggest revisions that would make them more willing to pass such a message along to members of their social network.

Findings from this pilot study will provide a strong foundation for the development of an intervention testing the effectiveness of electronic friend-to-friend colorectal cancer screening messages in older adults.

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Integrating cost communication into cancer care Direct link to this project

Project Staff:
  • Project Leader: Nora Henrikson, Group Health
  • Investigator: Diana Buist, Group Health
  • Investigator: Elizabeth Loggers, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2011

Area(s) of Research: Communication

Tumor Site(s): All

Phase(s) of Care: Treatment

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Emerging cancer therapies are some of the most expensive in all of medical care, often for relatively limited benefit to life or quality of life. Several recent international studies demonstrate that cost and cost effectiveness are increasingly important to clinical oncology and influence patient care, yet oncologists are ill-prepared to integrate these concepts into clinical care. Little is known about the perspectives and experience of oncologists and patients toward cost and cost effectiveness in US integrated health care systems.

We propose a pilot study to explore the beliefs and experiences of oncologists and patients in an integrated care system (Group Health Cooperative). Our primary research question is: how do oncologists and people with cancer use information on cost and cost effectiveness for decision making in clinical care? Our secondary question is: what strategies would best support clinician knowledge or use of cost or cost effectiveness data?

Our specific aims are:

  1. Understand oncologists’ practices in discussing treatment costs with patients
  2. Understand the needs of people with cancer in discussing costs of cancer treatment options with their oncologist

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Colonoscopy Adenoma Outcomes as Predicted by Lifestyle Risk Factors Direct link to this project

Project Staff:
  • Project Leader: Kenneth F Adams, HealthPartners Research Foundation

Funding Source: National Cancer Institute
Funding Start Date: 11/1/2010

Area(s) of Research: Outcomes; Behavior

Tumor Site(s): Colorectal

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Comparing Characteristics of CRN Melanoma Cases to the National SEER Database Direct link to this project

Project Staff:
  • Project Leader: Maryam Asgari, KP Northern California
  • Project Leader: Melody Eide, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 11/1/2010

Tumor Site(s): Skin

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The Colonoscopy Lookout Utilization and Effectiveness (CLUE) Study Direct link to this project

Project Staff:
  • Project Leader: Porat Ehrlich, Geisinger Health System

Funding Source: National Cancer Institute
Funding Start Date: 11/1/2010

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Screening Colonoscopy Efficacy for Reducing Risk of Death for Colorectal Cancer Direct link to this project

Project Staff:
  • Project Leader: Chyke Doubeni, Meyers Primary Care Institute
  • Project Leader: Robert Fletcher, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 9/1/2010

Area(s) of Research: Epidemiology & Surveillance; Comparative Effectiveness

Tumor Site(s): Colorectal

Phase(s) of Care: Screening

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Cancers of the colon and rectum (CRC), the second leading cause of cancer death in the US, can be detected at an early, more curable, stage or even prevented using available screening techniques. Although some expert groups in the US consider colonoscopy to be the standard, there is currently only limited direct evidence to support its increasing use for screening in average risk adults. Colonoscopy has higher risks and costs than other screening tests. Recent studies reported that colonoscopy did not reduce mortality from right-sided colon cancers, the part of the colon that is beyond the reach of sigmoidoscopy. However, those findings were controversial because that study was unable to distinguish screening from diagnostic uses or accurately assess the completeness of colonoscopies. This project's goal is to inform clinical and policy decisions by providing evidence to show whether the purported benefits of colonoscopy are realized in practice. The primary specific aim is to estimate the effectiveness of screening colonoscopy in reducing death from CRC among average-risk adults when compared to no screening, overall and separately for right- and left-sided cancers. Our secondary aims are to: 1) determine the impact of the completeness of colonoscopy examinations on its effectiveness; and 2) compare the effectiveness of screening colonoscopy relative to sigmoidoscopy. We will use a case-control design nested in an historical cohort of persons receiving care at 3 sites participating in a research consortium, Cancer Research Network (CRN). These sites provide the full continuum of cancer care to their members ranging from screening through end of life care, and provide access to information on CRC screening that can be linked to diagnosis and cause-specific mortality data on large numbers of racially and socioeconomically diverse persons. We will identify at least 1,200 cases of CRC deaths between 2007 and 2014 among enrollees who were 52 years or older at the date of the diagnosis, each matched within each health plan to two randomly selected controls based on age, sex and enrollment history. We will identify screening history for a minimum of 10 years prior to cancer diagnosis, differentiating screening from diagnostic procedures, using standardized targeted chart reviews and other sources. The sample size will provide sufficient power for separate evaluations of tumors located in the right colon. This project will be carried out by an experienced interdisciplinary team representing epidemiology, case-control methodology, biostatistics, gastroenterology and primary care. Team members are national leaders in CRC screening research and policy. This project is in synergy with existing NCI and the CRN goals to: 1) develop methods and approaches to provide clinical, policy-relevant information; and 2) inform clinical and public health decisions on CRC screening. This application is also responsive to the NCI's priority to improve understanding of the effectiveness and comparative effectiveness of tests used in screening for CRC, a "health disparity condition", and addresses Healthy People 2010 goals to reduce cancer death. PUBLIC HEALTH RELEVANCE: Colon cancer is the second leading cause of cancer death in the United States, but many of these cancers can be detected at an early, more curable, stage or even prevented using available screening techniques. Although many people believe that colonoscopy is the best screening test, there is currently no scientific evidence to support that claim. The goal of our proposed study is to provide scientific evidence on whether current beliefs about the benefits of colonoscopy screening are realized in actual clinical practice in order to help patients, doctors, and policy makers make decisions about colon cancer screening.

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Increasing Participation in Cancer Clinical Trials: Diversity Supplement Direct link to this project

Project Staff:
  • Project Leader: Carol Somkin, KP Northern California
  • Investigator: Tom Delate, KP Colorado
  • Investigator: Rena Pasick, University of California San Francisco

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2010

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Developing a Mental Health Data Resource Direct link to this project

Project Staff:
  • Project Leader: Greg Simon, Group Health
  • Investigator: Arne Beck, KP Colorado
  • Investigator: Enid Hunkeler, KP Northern California
  • Investigator: Frances Lynch, KP Northwest
  • Investigator: Karen Coleman, KP Southern California
  • Investigator: Leif Solberg, HealthPartners Research Foundation
  • Investigator: Robert Davis, KP Georgia
  • Investigator: Stephen Soumerai, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 7/8/2010

Area(s) of Research: Behavior; Comparative Effectiveness

Phase(s) of Care: Treatment

Description: minus sign Hide

Specific Objectives for the Proposed Research Network – The proposed network will establish the infrastructure necessary to efficiently conduct effectiveness research across the full range of mental health conditions and treatments. We will consider all stages of the process from initial observational studies, to selection of priority research questions, to efficient conduct of effectiveness and cost-effectiveness trials, to disseminating research results and implementing effective treatments. Long-term objectives include:

1) Develop large linked databases characterizing treatment exposures and outcomes – While observational studies have long used insurance claims records and pharmacy refill records, the growing use of electronic health records will allow access to rich data regarding treatment quality and outcomes for large, diverse populations. Moreover, rapid access to records data will allow research recruitment and data collection as treatment is occurring. New data extraction methods such as Natural Language Processing can identify and extract discrete data regarding clinical characteristics from text of clinical notes. As demonstrated in our previous research, linked records databases can be used for:

• Rapid and efficient enrollment into effectiveness trial

• Observational studies of treatment patterns and treatment effectivenes

• Identification of priority effectiveness questions for randomized trial

• Assessment of economic outcomes of treatme

• Studies of implementation, guideline dissemination, and policy evaluatin

2) Develop an efficient infrastructure for clinical outcome assessment – Many effectiveness questions can only be addressed by direct collection of clinical outcomes data. Efficiency of assessment is especially important in effectiveness research in order to reduce costs of research and minimize burden on study participants. We anticipate that effectiveness research will often rely on brief assessments administered via new communication technologies such as web-based questionnaires, electronic secure messaging, or interactive voice response. Methodologic research will be necessary to examine potential biases due to differential participation and use of brief assessments.

3) Use population-based data to select priority effectiveness questions – Representative data from real-world samples can identify the treatment decisions most often encountered in practice. In many cases, this population-based approach will identify different questions than those identified by efficacy researchers or commercial sponsors. For example, this approach would focus depression research on improving treatment selection and promoting treatment adherence rather than testing efficacy of individual drugs or resolving interdisciplinary debates regarding the efficacy of medication and psychotherapy.

4) Develop an efficient infrastructure for targeted clinical trials – If randomized trials, rather than market forces, are to guide dissemination of new treatments, findings must be available rapidly. Given the large number of effectiveness questions we must address, costs of study recruitment, treatment delivery, and outcome assessment must be dramatically reduced. New research models are necessary to:

• Rapidly and efficiently identify and enroll representative samples of patients treated in community settings using electronic medical records and population-based clinical registries

• Embed random assignment into care delivered by community providers and covered by health insurance

5) Develop infrastructure and capacity for assessing cost and economic impact of mental health treatment – As discussed above, a comprehensive assessment of treatment cost-effectiveness should include:

• Development of input cost assessment methods to estimate true costs of intervention delivery

• Use of health system claims and cost accounting records to assess effects on health services costs

• Use of survey and/or computerized records data to assess economic impacts from the perspective of employers, state governments, and other payers.

6) Use computerized records data to advance research on personalized treatment – Longitudinal records on large population-based samples will allow study of how individuals respond to similar and different treatments across multiple episodes of care, a critical step in identifying person-level predictors of treatment response. In addition, records databases will allow efficient identification of clinical subgroups to test specific hypotheses regarding personalized treatment.

7) Develop innovative methods for analysis of clustered longitudinal data – Observational studies in large population-based samples will remain an important tool of effectiveness research. The data necessary for these studies have a complex clustered structure: multiple treatment episodes per patient with episodes cross-clustered under treatments and providers. In addition, treatment choices and treatment adherence may be influenced by formulary policies and insurance coverage. Changes in treatment, adherence, and policies may introduce longitudinal confounding. Observational studies using these longitudinal, clustered data must integrate new techniques (such as hierarchical and marginal structural modeling) for aggregating treatment events into episodes of care, distinguishing between- and within-cluster variation across episodes, considering biased assignment of treatment, and accounting for random and systematic error in outcome assessments.

8) Develop and test effective methods for communication, dissemination, and implementation – Simple publication of effectiveness findings will not be sufficient to increase quality or decrease costs of treatment. Dissemination research is essential to identify the tools and incentives necessary to engage consumers, providers, employers, and insurers in improving efficiency of care. This research will include both experimental and quasi-experimental studies of implementation tools including: guidelines, provider education or detailing, social network mapping methods, provider prompts and reminders, formulary or administrative tools, financial incentives, direct-to-consumer marketing, and new communication technologies. This research must also identify specific components of interventions that contribute to both effectiveness and costs.

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HMORN METHODS Collaboratory Supplement Direct link to this project

Project Staff:
  • Project Leader: Eric Larson, Group Health
  • Investigator: Alan Stevens, Scott and White Health Care
  • Investigator: Brian Martinson, HealthPartners Research Foundation
  • Investigator: Dennis Ross-Degnan, Harvard Pilgrim Health Care
  • Investigator: Douglas Mapel, Lovelace Clinic Foundation
  • Investigator: Elizabeth Bayliss, KP Colorado
  • Investigator: Jerry Gurwitz, Meyers Primary Care Institute
  • Investigator: Karen Coleman, KP Southern California
  • Investigator: Laurie Habel, KP Northern California
  • Investigator: Les Kirchner, Geisinger Health System
  • Investigator: Lois Lamerato, Henry Ford Health System
  • Investigator: Melissa Butler, KP Georgia
  • Investigator: Pierre LaChance, KP Northwest
  • Investigator: Robert Davis, KP Georgia
  • Investigator: Robert T. Greenlee, Marshfield Clinic Research Foundation
  • Investigator: Sarah Greene, Group Health
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 6/15/2010

Area(s) of Research: Other

Description: minus sign Hide

This supplement award stems from interest on the part of the National Institutes of Health in enhancing the nation’s capacity to perform larger and more efficient interventions and analyses that collectively enable rapid responses to important questions in healthcare.

Over its 16 years of existence, the HMORN has contributed to path-breaking studies of cancer, cardiovascular disease, drug safety, maternal and infant health, and diabetes. The sites in the HMORN offer comprehensive data systems coupled with over 350 experienced scientists all working in highly regarded healthcare delivery systems. However, barriers remain to the Network fully leveraging the potential of its collective resources. The Collaboratory supplement is geared toward understanding the HMORN’s organizational structure and capacity in three areas: governance and operations; overall research portfolio and potential gaps in capacity; and data resources. A thoughtful analysis of the HMORN’s current and needed capabilities will accelerate its overall structural and scientific development.

The NIH Director, Dr. Frances Collins has identified three scientific areas the HMORN is particularly well-suited to address: practical and efficient clinical trials conducted in real-world settings; large epidemiology studies that employ high-throughput analysis of exposures and outcomes, utilizing the array of data sources within HMORN health systems; and health care delivery research that enables understanding of how changes in delivery models and structures can improve care.

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Does Weight Loss Among Postmenopausal Women Decrease Risk of Breast Cancer? Direct link to this project

Project Staff:
  • Project Leader: Heather Feigelson, KP Colorado
  • Investigator: Cynthia Nakasato, KP Hawaii
  • Investigator: Diana Buist, Group Health
  • Investigator: Sharon Hensley Alford, Henry Ford Health System
  • Investigator: Steve Waring, Marshfield Clinic Research Foundation
  • Investigator: Thomas Vogt, KP Hawaii

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2010

Tumor Site(s): Breast

Phase(s) of Care: Prevention

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Weight gain and high body mass index (BMI) are well recognized risk factors for postmenopausal breast cancer, but the association between weight loss and breast cancer is not well understood. Only a few studies have examined whether weight loss can reduce risk among postmenopausal women. The Cancer Research Network (CRN) and the virtual data warehouse (VDW) may provide an excellent platform for examining this important health question. This is a revised resubmission of a pilot proposal submitted to the CRN last year. While the reviewers cited several strengths, criticisms included the need for pilot data. The reviewers suggested that the proposal be focused on creating a distributed VDW program to determine data availability at different sites. The current proposal will present pilot data from the Kaiser Permanente Colorado (KPCO) VDW and determine the availability and quality of similar data across multiple CRN sites. Specifically, we plan to: 1) Develop a distributed VDW program to determine the availability and quality of data across CRN sites that could be used to examine whether weight loss is associated with decreased risk of breast cancer, or decreased risk of breast cancer recurrence. 2) Conduct preliminary analyses of these data to demonstrate that sufficient data exist in the VDW to appropriately inform an RO1 (or similar mechanism). In particular, whether multiple measures of weight are captured over time, and whether information of important covariates, such as HRT use, exist in the VDW. To complete these aims, we will create and distribute a VDW program at KPCO that will be executed at multiple CRN sites. The VDW program will create tabular data of variables of interest to conduct a complete analysis of weight change and breast cancer. In particular, availability of weight at multiple time periods before and after breast cancer diagnosis will be determined.

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Establish a Prospective Cohort to Investigate Obesity, Diabetes and the Metabolic Syndrome as Risk Factors in Young Adult Cancer Direct link to this project

Project Staff:
  • Project Leader: Corinna Koebnick, KP Southern California
  • Investigator: Larry Kushi, KP Northern California

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2010

Area(s) of Research: Biology & Etiology

Tumor Site(s): Breast; Other

Phase(s) of Care: Screening; Diagnosis

Description: minus sign Hide

Although cancer represents one of the leading causes of disease-related deaths in young adults (20-39 years), little attention has been given to risk factors for cancers in this population. This is particularly important given the increasing evidence that a substantial proportion of the cancers in young adults have a different biology, and probably etiology/pathogenesis, than found in older persons. Despite some reports from studies in middle-aged to older adults, the association between obesity, diabetes, the metabolic syndrome, and the most common cancers in young adults remains poorly understood. However, this knowledge may help to improve cancer screening and diagnosis. The goal of the proposed pilot study is to pave the way for future research on risk factors for cancer in young adults utilizing the memberships of the KPSC and KPNC health plans. The specific aims of this proposed research are (1) to establish a prospective population-based cohort of about 1.5 million young adults to investigate the association between obesity, diabetes, metabolic syndrome and cancer, and (2) to describe the completeness of exposure and confounding variables in these CRN sites. Initial efforts will focus on the most common cancers in young adults -- thyroid, testicular, and breast. Importantly, the cohort will serve as a potential resource for CRN and other scientists seeking to collaborate on studies of less common and rare cancers in young adults, such as colorectal and brain cancers. Thus, the proposed pilot study will lay the foundation for future R01-funded studies focused on the longitudinal association between obesity, diabetes, the metabolic syndrome and the risk for breast, thyroid and testicular cancer in young adults. These studies will provide information necessary to overcome the disparities in screening for and diagnosis of cancer in young adults.

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Lymph Node Examination in Colorectal Cancer: Predictors of Adequate Staging and Its Influence on Cancer Survival in Community Practice Direct link to this project

Project Staff:
  • Project Leader: Adedayo A. Onitilo, Marshfield Clinic Research Foundation
  • Investigator: Jessica Engel, Marshfield Clinic Research Foundation
  • Investigator: Po-Huang Chyou, Marshfield Clinic Research Foundation

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2010

Area(s) of Research: Outcomes; Quality of Care

Tumor Site(s): Colorectal

Phase(s) of Care: Diagnosis; Treatment

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Background

Colorectal cancer is the third leading cause of cancer incidence and mortality among men and women in the United States. In 2009, the American Cancer Society projects that 146,970 colorectal cancers will be diagnosed; and 49,920 people will die of the disease. Surgery is curative for colorectal cancer, yet up to 30% of stage I - II cases die of disease recurrence or metastasis. In these cases it is likely there was undetected extracolonic disease at the time of diagnosis and surgery, often because of inadequate harvesting of lymph nodes. Stage III (node positive) cases receive chemotherapy as standard adjuvant treatment, reducing disease-specific mortality by 30%. Suboptimal lymph node harvesting during surgery can understage the patient, causing potentially life-saving adjuvant therapy to be withheld. Conversely, administration of chemotherapy to “truly” node-negative patients because of inadequate nodal dissection has not translated into clinical benefit and may expose those patients to the unnecessary toxicity of chemotherapy. Despite the agreed-upon importance of lymph node harvesting to stage and treat colorectal cancer appropriately, disagreement about the number needed for adequate prognosis and treatment, and important covariate factors, continues.

Specific Aims

1) To assess the adequacy of nodal recovery at surgery in colorectal cancer patients by retrospective analysis of tumor and node data.

2) To better define “adequate lymph node recovery” by exploring associations between adequacy of lymph node harvesting and patient survival using various definitions of “adequacy”.

3) To determine factors that may influence adequacy of nodal recovery, including patient,provider and system variables.

Methods

This pilot is a retrospective analysis of Marshfield Clinic patients diagnosed from January 1, 1992 through December 31, 2008 with histologically confirmed primary colorectal cancer, stages I-III, definitively resected. The Cancer Registry, Electronic Medical Record, and CRN Virtual Data Warehouse will provide comprehensive data on demographics, co-morbidities, surgery, lymph node status, first definitive treatment, recurrence, and survival.

Significance

This pilot proposes to study adequacy of lymph node staging and survival outcomes for stage I-III colorectal cancer patients. This pilot will develop proven methodology and preliminary data for a CRN-wide RO1 proposal to better determine an important diagnostic and prognostic variable of one of the most important cancers in the United States. If successful, the study can lead to improved clinical management of colorectal cancer and help the CRN provide a major clinical contribution to cancer care.

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Non-melanoma skin cancer ascertainment in the HMO Direct link to this project

Project Staff:
  • Project Leader: Melody Eide, Henry Ford Health System
  • Investigator: Mark Tuthill, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2010

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Skin

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More than one million nonmelanoma skin cancers (NMSC), including squamous cell carcinoma (SCC) and basal cell carcinoma (BCC), will be diagnosed in the United States (US) in 2008. Despite the large population affected and personal, societal and economic burdens, the epidemiology of NMSC is understudied. This may be because large cancer registries often exclude NMSC, including the SEER program. Secondary data analysis has been limited because SCC and BCC do not have unique International Classification of Disease (ICD-9) identifiers. The CRN could serve as a resource in which to study NMSC etiology, health services and economic resource utilization, and behavioral interventions. We submit a proposal to develop the CRN’s capacity to serve as a “virtual registry” to study NMSC. We plan to compare algorithms for identifying NMSC in the claims data of HFHS using the Virtual Data Warehouse (VDW) which will be validated again pathology information. The sensitivity, specificity, positive and negative predictive values will be calculated. This pilot project will further the development of the infrastructure of the CRN to allow for identification of NMSC. We will also identify the resources and additional artnerships necessary for the generation of future NIH proposals with the aim of eventually developing technology capable of distinguishing the NMSC subtypes.

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Studying Communication over the Cancer Care Continuum: A Feasibility Study Direct link to this project

Project Staff:
  • Project Leader: Kathleen Mazor, Meyers Primary Care Institute
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Gwen Alexander, Henry Ford Health System
  • Investigator: Sarah Greene, Group Health
  • Investigator: Tom Gallagher, University of Washington

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2010

Area(s) of Research: Communication

Phase(s) of Care: Treatment

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Effective communication is a cornerstone of patient-centered cancer care. Unfortunately, many cancer patients report serious breakdowns in cancer communication, sometimes with devastating effects. These breakdowns occur with a variety of providers across the care continuum. Preventing breakdowns and mitigating their harmful effects requires an understanding of their antecedents and consequences. Most studies of cancer communication rely on retrospective patient reports, which are subject to multiple sources of error and confounding. Less frequently, studies have included actual recordings, usually focused on a single provider on a single occasion focus, and longitudinal tracking of important outcomes has been missing. Thus, substantial gaps in our understanding of cancer communication remain. Our goal is to conduct a multi-site study involving prospective, longitudinal recording of provider-patient interactions throughout the cancer care continuum. By studying encounters in real time, over time and over many providers, we will better understand these interactions and their impact on patient outcomes. This study will address questions such as: How often do communication breakdowns occur? What risk factors exist? Can subsequent encounters repair the harm caused by poor communication? To successfully conduct such a study, we must understand the practical, technical, ethical, and regulatory challenges involved in proposing, recruiting and implementing such a study. The objective of this pilot study is to conduct in-depth interviews with patients, providers, IRB heads, and leaders at four CRN sites to identify potential barriers and enablers of longitudinal audio-recording of encounters, and ways to enhance acceptability of the planned research all stakeholders. We will also recruit cancer patients to keep communication diaries, making note of all cancer care encounters (telephone, in-person and email) and their appraisal of each encounter’s impact. Findings will inform a future R01 proposal, one that is responsive to NCI’s interest in patient-centered cancer communication across the cancer care continuum. It will also enhance the CRN’s capacity for cancer communication research.

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Antidepressants and Breast Cancer Pharmacoepidemiology Direct link to this project

Project Staff:
  • Project Leader: Reina Haque, KP Southern California
  • Investigator: Suzanne Fletcher, Harvard Pilgrim Health Care
  • Investigator: Virginia Quinn, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 4/15/2010

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Breast

Phase(s) of Care: Treatment

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ABC: Antidepressants & Breast Cancer Treatment Pharmacoepidemiology Tens of thousands of American women with breast cancer are taking tamoxifen to reduce their chances of developing a recurrence or second primary breast cancer. Many of these women also take antidepressants. Because tamoxifen has side effects that diminish a woman's quality of life and quality of sleep including hot flashes, night sweats, and depression, and because hormone replacement therapy is contraindicated for women with breast cancer, antidepressants increasingly have been used to relieve symptoms caused by tamoxifen. In addition, antidepressants are commonly prescribed for approximately 50% of women experiencing depression subsequent to a breast cancer diagnosis. Recent evidence suggests selective serotonin reuptake inhibitor (SSRI) antidepressants may reduce the metabolism of tamoxifen to its active form, which could reduce tamoxifen's protection against recurrent or a second primary breast cancer. This possibility needs investigation. As result of a few small studies, some recent reports caution physicians against prescribing SSRI medications concurrently with tamoxifen. However, findings from two clinical studies are ambiguous. Only one small study reported an association between antidepressants and breast cancer mortality in women taking tamoxifen while another found no association. Importantly, to date no study has adequately measured antidepressant use. Because tens of thousands of women are likely taking both tamoxifen and antidepressants, it is critical to determine if SSRIs indeed decrease the protection of tamoxifen against subsequent breast cancer among breast cancer survivors. The goal of this project is to investigate whether concomitant use of antidepressants and tamoxifen increases the risk of subsequent breast cancer (recurrence or second primary tumor) among women who have been diagnosed with a first primary breast cancer, compared to similar women treated only with tamoxifen. From a SEER-affiliated electronic tumor registry serving over 6 million members, we will assemble a large cohort of over 25,000 women diagnosed with a first early stage estrogen receptor positive breast cancer and treated with tamoxifen (of whom approximately 12,000 were exposed to antidepressants). Using a health plan's comprehensive pharmacy database, we will determine which women were also treated with SSRI or other antidepressants. We will then identify all women who developed a subsequent breast cancer and those who remained breast-cancer free in this cohort to determine if SSRIs or other antidepressant use is associated with an increased risk of subsequent breast cancer. Finally, using a case-control nested study within the cohort, we will determine if certain factors confound or modify the association. This innovative "ABC" (Antidepressants & Breast Cancer) study presents the first real opportunity to determine if women who take both tamoxifen and antidepressants following their initial breast cancer have a greater likelihood of developing subsequent breast cancer than women exposed to tamoxifen who do not take SSRIs or other antidepressants. PUBLIC HEALTH RELEVANCE: This study will determine if combined use of antidepressants (including SSRIs or other types) and tamoxifen poses serious health threats among breast cancer survivors by elevating subsequent breast cancer risks, compared to women who were only exposed to tamoxifen. As both depression and hot flashes are common in breast cancer patients, information about the safety or the adverse effects of combined tamoxifen and antidepressant use would have far reaching clinical implications in treating the depression and hot flashes after a diagnosis of breast cancer. If an association is not found, this would provide reassurance to continue prescribing certain antidepressant medications to women diagnosed with breast cancer.

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Outcomes of Prostate Cancer Androgen Deprivation Therapy Direct link to this project

Project Staff:
  • Project Leader: Arnie Potosky, Georgetown University
  • Investigator: Andrea Cassidy, Henry Ford Health System
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Reina Haque, KP Southern California
  • Investigator: Stephen K. Van Den Eeden, KP Northern California

Funding Source: National Cancer Institute
Funding Start Date: 4/2/2010

Area(s) of Research: Outcomes

Tumor Site(s): Prostate

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We propose to assess fatal and morbid outcomes up to 15 years following androgen deprivation therapy (ADT) for men initially diagnosed with localized prostate cancer.

In addition to lack of evidence of a mortality benefit, there is emerging evidence suggesting that ADT may be associated with increased cardiovascular mortality, as well as musculoskeletal (bone fractures), cardiovascular, and endocrine-related (diabetic) events. Our three specific aims include estimating the benefits and risks of ADT in terms of all cause and prostate-cancer specific mortality, estimating the rate of serious non-fatal adverse events; and assessing whether commonly used prescription medications can lessen the harms associated with ADT. We will assess cancer-specific outcomes according to prognostic risk groups defined by age, stage, serum biomarker values (PSA), and other pathological markers of tumor aggressiveness. For adverse event estimates, we will account for variations in baseline comorbidity and clinical predictors, and will use state-of-the-art effectiveness analysis techniques to correct for selection bias.

The retrospective observational study will be conducted using a large, diverse population of over 45,000 men diagnosed from 1995-2007 with a mean follow up of 6 years. There are comprehensive computerized clinical utilization data for this population from 3 large integrated health care plans, including longitudinal information on tumor characteristics, risk factors and outcomes. Key variables will be derived from inpatient, outpatient, pharmacy and radiology data and lab test values. In contrast to prior observational studies, ours will have the combination of size, follow up, and detailed clinical information over the entire disease trajectory needed to significantly improve the precision of risk estimates associated with ADT. These strengths, and our multi-disciplinary team experienced in prostate cancer outcomes research using large databases, will yield new and important information needed to improve treatment decision making and outcomes.

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Inflammation-related medication use and risk of lymphoma Direct link to this project

Project Staff:
  • Project Leader: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Chun Chao, KP Southern California
  • Investigator: Denise Boudreau, Group Health
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Joan Fortuny, Catalan Institute of Oncology
  • Investigator: Larry Engel, Memorial Sloane Kettering Cancer Center
  • Investigator: Laurie Habel, KP Northern California
  • Investigator: Leslie Spangler, Group Health
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Marsha Raebel, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 4/1/2010

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Lymphoma

Phase(s) of Care: Prevention

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Using a nested case-control study design, we will identify lymphoid malignancies among these CRN populations. Population-based cancer registries will be used to identify new cases of lymphoid malignancies diagnosed from1998-2007; membership files will be used to identify controls. Pharmacy databases will be used to identify prescriptions for statins and other medications in order to assess the association between statin use and the risk of lymphoma overall and by lymphoma subtype. The secondary objective, led by Dr.Chao at KPSC, is to assess the association of statin use and lymphoma risk among patients with selected predisposing autoimmune disorders. The hypothesis is that a protective association between statin use and lymphomas will be stronger for lipophilic statins and for lymphoma subtypes that are more closely related to chronic inflammation.

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Algorithms to Identify Second Breast Cancer Events from Electronic Data Direct link to this project

Project Staff:
  • Project Leader: Jessica Chubak, Group Health
  • Investigator: Lois Lamerato, Henry Ford Health System
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 1/4/2010

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Breast

Phase(s) of Care: Survivorship

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U.S. breast cancer survivors number 2.5 million, more than the survivors of any other cancer. Studies on how to improve survival and quality of life in this ever-growing population are critical in reducing the national cancer burden. The ability to identify second breast cancer events (i.e., breast cancer recurrences and second primary breast cancers) is critical for cancer survivorship research. In response to the National Cancer Institute's call for studies of cancer surveillance using health claims data, we propose to develop and validate algorithms to identify second breast cancer events from automated healthcare utilization data in order to minimize the need for expensive and time-consuming manual medical record review. Automated healthcare utilization data are becoming increasingly accessible; however, these sources have yet to be validated against gold-standard medical record abstraction for obtaining information on second breast cancer events. This work is significant and necessary since state tumor registries do not routinely collect information on cancer recurrences. The proposed study will be conducted using data from two integrated healthcare delivery systems within the Cancer Research Network (CRN): Group Health Cooperative (in western Washington State) and the Henry Ford Health System (in Detroit, Michigan). These healthcare systems have extensive automated data on enrollment, diagnoses, procedures, and prescription medication fills. The proposed study is efficient because it will use gold-standard data on second breast cancer events that have already been abstracted on ~2500 women as part of previously funded studies of breast cancer outcomes. The sample of women will be divided into a training dataset (60%) for algorithm development and a testing dataset (40%) for validation. The primary aim of this study is to develop a "menu" of algorithms that researchers can select from under different circumstances; i.e., when they want to maximize sensitivity, specificity, or positive predictive value. Secondary analyses will explore: 1) whether algorithms developed in one population are valid in another, and 2) whether valid algorithms can be developed using more limited sources of data that are likely to be available in a larger number of healthcare settings. This project will use innovative approaches to develop the algorithm "menu" and to explore the generalizability of algorithm development.

PUBLIC HEALTH RELEVANCE: As the number of breast cancer survivors grows, research on breast cancer prognosis and quality of life is becoming increasingly important to public health; however, current methods for collecting data on breast cancer recurrences and second primary breast cancers are either time-consuming and costly or have not yet been validated. Being able to identify cancer breast cancer outcomes from automated healthcare data is necessary for conducting large-scale, population-based studies to identify and modify factors that impact the prognosis and quality of life of women with breast cancer.

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Developing Melanoma Screening in Primary Care Direct link to this project

Project Staff:
  • Project Leader: Marty Weinstock, Brown University
  • Project Leader: Sheila Weinmann, KP Northwest
  • Investigator: Alan Geller, Harvard University
  • Investigator: Allan Halpern, University of Michigan
  • Investigator: Maryam Asgari, KP Northern California
  • Investigator: Melody Eide, Henry Ford Health System
  • Investigator: Suzanne Fletcher, Harvard Pilgrim Health Care

Funding Source: American Cancer Society
Funding Start Date: 1/1/2010

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An increasing body of evidence indicates that effective early detection is our best hope for cutting melanoma deaths by at least half in the near future. Conventional education programs have had the effect of stabilizing mortality rates despite steadily increasing incidence trends, but we need to change our methods to get a substantial reduction in deaths. Today, knowledge and skills for melanoma screening remains low in primary care, performance of thorough skin self-examination remains low, and education of clinicians remains focused on teaching variations of the “ABCD”s of melanoma in conventional formats. We propose to develop an early detection training program that is web-based for widespread use, grounded in the realities of primary care delivery, and which includes a deeper image database and web-based format that together will allow a quantum leap in interactivity compared to prior efforts in melanoma, both to engage the learner and to improve the training achieved upon completion. Further, this training will incorporate dermoscopy (epiluminescence microscopy) which today is rarely used in primary care despite its proven ability to improve accuracy of the clinical examination. We have assembled a diverse team from multiple institutions with expertise and experience in melanoma early detection, medical education for cancer prevention, interventions with a variety of clinicians, and in large health systems, screening, and web-based instruction. We will measure both improvement in skills and effect on the health delivery system. This will provide a key exportable tool for mortality reduction efforts, including large definitive trials and health campaigns.

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Uptake and Consequences of MRI for Breast Cancer Screening in Community Settings Direct link to this project

Project Staff:
  • Project Leader: Natasha Stout, Harvard Pilgrim Health Care
  • Investigator: Dennis Ross-Degnan, Harvard Pilgrim Health Care
  • Investigator: Diana Buist, Group Health
  • Investigator: Larissa Nekhlyudov, Harvard Pilgrim Health Care
  • Investigator: Marjorie Rosenberg, University of Wisconsin
  • Investigator: Sue Goldie, Harvard University
  • Investigator: Suzanne Fletcher, Harvard Pilgrim Health Care

Funding Source: American Cancer Society
Funding Start Date: 1/1/2010

Area(s) of Research: Economics; Epidemiology & Surveillance; Outcomes

Tumor Site(s): Breast

Phase(s) of Care: Screening

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The objective of this project is to characterize the use, clinical outcomes and economic consequences of magnetic resonance imaging (MRI) for breast cancer screening in the community. Recent clinical guidelines have expanded recommendations for screening breast MRI potentially affecting over one million women. Screening breast MRI offers higher sensitivity compared with mammography but lower specificity and much higher cost. Originally studied in high-risk groups and controlled settings, MRI performance may differ dramatically when used in broader populations. Our research aims are to: 1) Characterize over a decade of screening breast MRI use in a community setting; 2) Quantify clinical outcomes and use of follow-up testing; and 3) Evaluate the economic consequences of screening breast MRI. We will analyze electronic health data from women receiving breast MRI from 2000-2013 at Atrius Health, a large multi-center group practice in Massachusetts serving nearly 600,000 patients. Results will be integrated into a decision-analytic simulation model of breast cancer epidemiology to assess the cost-effectiveness of screening breast MRI as practiced in the community. Analysis of population-based electronic health data combined with decision-analytic modeling provides a powerful means to address important and timely questions in cancer prevention and control.

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Expansion of the DEcIDE DRN Infrastructure to Support Studies of Comparative Effectiveness Direct link to this project

Project Staff:
  • Project Leader: Rich Platt, Harvard Pilgrim Health Care

Funding Source: Agency for Healthcare Research and Quality
Funding Start Date: 12/1/2009

Description: minus sign Hide

Background

Clinical, administrative, and other kinds of health care information from very large populations provide a valuable resource for investigating the potential harms and benefits of treatments in different patient groups and across different settings of care. A distributed network supports AHRQ’s Effective Health Care goals to conduct patient-centered research by providing standardized and re-usable information technology approaches that may speed the initiation and conduct of comparative effectiveness studies through the DEcIDE program. A fully-operational distributed research network (DRN) may also allow for rapid evidence generation on the effects of new treatments and other medical technologies. In addition, a fully operational system may make actionable information available in a more timely way than traditionally occurs in standard research environments. In the first phase of this pilot project, DEcIDE investigators developed the design specifications for a scalable DRN, created a prototype for the network (see http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=316), performed a study using distributed research principles assessing the comparative effectiveness of second line anti-hypertensive therapy, and created a blueprint for implementing a distributed research network. This next phase of the project builds upon that initial work.

Objectives

This is the second phase of a project to continue testing and to implement a distributed research network infrastructure that supports patient-centered studies and collaborative research on comparative effectiveness. The objectives of the project are to:

1) Expand the one DRN model that was created in phase 1, including enhancing the security, scientific capacity, governance structure, and functionality of the application and web portal to address questions of comparative effectiveness;

2) Institute a DRN Stakeholder Committee;

3) Develop new research topics nominated from stakeholders for comparative effectiveness using the DRN;

4) Enhance secure access control to the DRN; and

5) Collaborate with the other DEcIDE investigators testing other models to implement DRN’s.

Methods

The project will make operational a scalable data network that supports secure analyses of electronic information across multiple organizations. With appropriate IRB protection of human rights and privacy, investigators will build on the prototype developed during the first phase of work to expand the network’s technical capabilities, develop governance policies, create an array of partnerships to stimulate use of the network, and collaborate with AHRQ to disseminate the findings of this work. Activities will include substantially enhancing the functionality of the existing DRN prototype, creating operational network “nodes” that include four or more large health plan sites, investigating the technical requirements needed to perform distributed multi-variate analysis using network resources, developing a governance plan for the use of the network resources, updating a million member DRN research dataset created during phase 1, convening a stakeholder group to advise on the use of network resources, using the recommendations of this group to select a study that uses the expanded dataset, collaborating with 2 of AHRQ’s DEcIDE research consortia to develop research proposals that would take advantage of the future DRN, collaborating with DARTNet (another DEcIDE DRN project), and participating with AHRQ in programs that disseminate the project findings and engage relevant stakeholders.

Expected Outputs

Six scientific and technical reports are anticipated:

Final Report #1 - Design Specifications for Expanded DRN

Final Report #2 - Comprehensive Research Protocol for Use of the Distributed Hypertension Dataset

Final Report #3 - Research Reports Resulting from the Comprehensive Research Protocol

Final Report #4 - Collaborative Research Topics & Protocol Outlines Developed with DEcIDE Consortia

Final Report #5 - Secure Access Control to the DEcIDE DRN (Research Manuscript with extended appendices)

Final Report #6 - Stakeholder Committee Meeting Reports

Expected date of project completion: 12/30/11

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Building CER Capacity: Aligning CRN, CMS and State Resources to Map Cancer Care Direct link to this project

Project Staff:
  • Project Leader: Debra Ritzwoller, KP Colorado
  • Project Leader: Jane Weeks, Dana Farber Cancer Institute
  • Investigator: Deborah Schrag, Memorial Sloane Kettering Cancer Center
  • Investigator: Ed Wagner, Group Health
  • Investigator: Larry Kushi, KP Northern California
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Paul Fishman, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2009

Area(s) of Research: Comparative Effectiveness

Tumor Site(s): Breast; Cervical; Colorectal; Lung; Prostate

Phase(s) of Care: Treatment; End of Life

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Through a partnership between investigators in the Cancer Research Network (CRN) and Dana-Farber/Harvard Cancer Center, we propose to develop a resource with sufficient depth and breadth to support high quality cancer comparative effectiveness research (CER) addressing two key knowledge gaps. First, we will focus on treatment of advanced disease. Advanced cancer results in the bulk of deaths, morbidity, and expenditures. Moreover, the evidence base for treatment of advanced disease is often thin and based on expert consensus achieved through extrapolation from small efficacy studies in highly selected cohorts. The second key gap we will address is the relative dearth of population-based research on patterns and outcomes of cancer care for patients who aren't represented in SEER-Medicare, the dominant data source in the field, namely, patients younger than 65, those receiving their care in an HMO, and the poor. We will capitalize on pre-existing infrastructure with focused activities aimed at selective enhancement of resources to support CER studies in patients with advanced cancer. Specifically, we will: Aim 1. Build broad capacity by assembling national data sets (CRN, SEER-Medicare, Medicaid, and NCCN) to support studies of patterns of care and outcomes among patients with advanced cancer and developing, validating, and implementing strategies to enhance the accuracy of key data elements; Aim 2. In one region (California) augment the patient level data from the national sources in Aim 1 with regional data on supply to build a comprehensive cancer "map" of the region; Aim 3. Test capacity and understand limitations of the data systems assembled in Specific Aims 1 and 2 by conducting 5 "use case" analyses that describe patterns of care for select decisions in advanced cancer that span the major treatment modalities, have significant clinical or economic ramifications, and are likely influenced by patient, provider, and/or health system factors; and Aim 4. Launch CE analyses that capitalize on the resources developed and tested in Aims 1-3 by (a) conducting analyses to fully determine the CE of two interventions for advanced cancer, (b) designing and vetting a CE trial appropriate for the CRN, and (c) partnering with NCI to convene a national stakeholders meeting where project data will be presented and strategies for future CER research in cancer discussed. This project will create a sustainable resource for cancer CER, generate new and improved methods to help advance the field of cancer CER, and provide insights into the nature and causes of variation in important patterns of cancer care. It will also lay the groundwork for future cancer CER research by exploring the feasibility of CE trials in the CRN and engaging national stakeholders in a discussion of future research directions. PUBLIC HEALTH RELEVANCE: Advanced cancer is an ideal topic for comparative effectiveness research because the existing evidence base is less well-developed than for early disease, and the potential impact of CER therefore greater. The primary beneficiaries of this work will be cancer patients, since a better understanding of the most effective strategies of care could lead to meaningful improvements in the length and quality of their lives. But policy-makers and taxpayers could benefit as well, if this research reveals that patients at the end of life are receiving care that is not only ineffective, but also costly.

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Comparative Effectiveness Research in Genomic & Personalized Medicine of Colorectal Cancer Direct link to this project

Project Staff:
  • Project Leader: Katrina Goddard, KP Northwest
  • Project Leader: Larry Kushi, KP Northern California
  • Investigator: Alanna Rahm, KP Colorado
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Andy Nelson, HealthPartners Research Foundation
  • Investigator: Carol Somkin, KP Northern California
  • Investigator: Catherine A. McCarty, Marshfield Clinic Research Foundation
  • Investigator: Gwen Alexander, Henry Ford Health System
  • Investigator: Heather Feigelson, KP Colorado
  • Investigator: Michael Maciosek, HealthPartners Research Foundation
  • Investigator: Richard Meenan, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2009

Area(s) of Research: Genetics; Comparative Effectiveness

Tumor Site(s): Colorectal

Phase(s) of Care: Screening; Treatment

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Background

In recent years, genomic or other molecular tests have been recommended for clinical practice in the area of cancer treatment. They are used to identify individuals at high risk, screen and perform early detection, identify prognostic markers, and guide course of therapy. We propose a focused program of research that will investigate the comparative effectiveness of several tests related to colorectal cancer. The proposed study is a collaboration of several of the member sites of the NCI-funded Cancer Research Network (CRN) and academic partners.

Objective

Our comprehensive research program in GPM for colorectal cancer will have two main components: 1) secondary data collection through evidence synthesis and cost-effectiveness analysis, and 2) primary data collection through a proof-of-principle study to examine questions about personalized medicine for colorectal cancer. In the proof-of-principle study, we will evaluate the utilization of KRAS and Lynch Syndrome genetic tests within our health systems, and measure the effectiveness of KRAS testing compared with a patient population that does not receive testing. We will also conduct patient and physician interviews to measure psychosocial issues related to KRAS testing, and to help us understand how the genetic test results are used to inform decisions. Our research program in colorectal cancer will build the experience, data systems, and methods that can apply to other cancer-related genetic or molecular tests in the future, such as UGT1A1 testing, or Oncotype DX and CYP2D6 testing for breast cancer. The interwoven research program that we propose will provide opportunities for synergy between teams of researchers conducting primary and secondary data collection.

Public Health Relevance

We will study several genetic tests related to colon cancer that may help doctors understand who will get colon cancer and what therapies some patients should receive. We will study who gets tested, how the genetic test result helps people decide what to do, and whether patients have different health outcomes when they get tested. We will also summarize research that has already been published and analyze cost information about the use of these tests.

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Cost-Effectiveness of Hormonal Therapy for Clinically Localized Prostate Cancer Direct link to this project

Project Staff:
  • Project Leader: Stephen K. Van Den Eeden, KP Northern California
  • Investigator: Arnie Potosky, Georgetown University
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2009

Area(s) of Research: Comparative Effectiveness

Tumor Site(s): Prostate

Phase(s) of Care: Treatment

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This application addresses broad Challenge Area (05) entitled "Comparative Effectiveness Research (CER)". Within that area, we are addressing the specific high priority challenge topic 05-CA-104* Comparative Effectiveness Research on Cancer Treatment. Our application also responds to the specific challenge topic 04-CA-110 Treatment of Prostate Cancer. Androgen Deprivation Therapy (ADT) has become increasingly used as primary monotherapy for older men with newly diagnosed localized disease not receiving other curative treatments (surgery or radiotherapy), despite the fact that there is no proven mortality benefit from clinical trials. Given the increasing number of elderly men, the high incidence and survival rates from prostate cancer, and the use of ADT in one-third of 2 million men newly diagnosed or surviving with prostate cancer, there is a growing need for information on effectiveness and costs to inform policy and treatment decisions. Clinical trials are not ongoing or likely to be conducted to address these issues. To address the limitations of prior observational database studies, we propose a new comparative effectiveness study to provide information on the risks and potential benefits of immediate ADT in men diagnosed with localized prostate cancer. Our three aims include estimating the comparative effectiveness of immediate ADT versus observation in terms of all cause and prostate-cancer specific mortality and progression-free survival, estimating the longitudinal direct medical care costs to capture the impact of ADT, and calculating the cost- effectiveness (cost per life years saved) and cost-utility (quality-adjusted life years) using published patient utilities for multiple prostate cancer health states. We will assess all outcomes according to prognostic risk groups defined by age, stage, serum biomarker values (PSA), and other pathological markers of tumor aggressiveness. We will account for variations in baseline comorbidity and sociodemographic factors, and use state-of-the-art comparative effectiveness techniques to address selection bias. The retrospective observational study will be conducted using a large, diverse population of nearly 10,000 men with localized disease diagnosed from 1995-2007 with a mean follow up of 6 years. There are comprehensive computerized clinical utilization data for this population from 2 large integrated health care plans, including longitudinal information on tumor characteristics, risk factors and outcomes. Key variables will be derived from inpatient, outpatient, pharmacy and radiology data and lab test values. In contrast to prior observational studies, ours will have the combination of size, follow up, and detailed clinical information over the entire disease trajectory needed to significantly improve the precision of estimates of mortality and progression-free survival following ADT in sub-groups of men at varying levels of baseline risk. These strengths, and our multi-disciplinary team experienced in prostate cancer research using large databases, ensure that our results will be useful to improve practice, policy, and health outcomes. This is a multisite study to investigate the Challenge Area of Comparative Effectiveness Research on Cancer Treatment and specifically the Treatment of Prostate Cancer. We propose a new comparative effectiveness study to provide information on the risks and potential benefits of immediate ADT in men diagnosed with localized prostate cancer using data from two integrated health delivery systems with access to comprehensive health, utilization, cost, and socioeconomic data.

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Improving breast cancer surgery effectiveness through establishment of an electronic cancer surgery database Direct link to this project

Project Staff:
  • Project Leader: Larry McCahill, Van Andel Research Institute
  • Investigator: Adedayo A. Onitilo, Marshfield Clinic Research Foundation
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Ed Wagner, Group Health
  • Investigator: Erin Aiello Bowles, Group Health
  • Investigator: Heather Feigelson, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2009

Area(s) of Research: Quality of Care; Comparative Effectiveness

Tumor Site(s): Breast

Phase(s) of Care: Treatment

Description: minus sign Hide

This application addresses broad Challenge Area (04) Clinical Research and the specific Challenge Topic, 04-CA-111: Quality of Cancer Surgery and Outcomes. This application also has specific relevance to broad challenge area (05) Comparative Effectiveness Research and specific Challenge Topic 05-CA-104: Comparative Effectiveness Research on Cancer Treatment. Despite the frequency of breast cancer surgery worldwide, there remains a paucity of data for surgical outcomes discernable at the surgeon or hospital level. Recent measures of surgical quality have been proposed for breast cancer surgery. This application seeks to combine the expertise of the University of Vermont in cancer surgery outcomes assessment with expertise of the Cancer Research Network (CRN), a network of investigators at the forefront of cancer-related effectiveness research. There is currently no available healthcare administrative database which will allow comparative effectiveness research of initial breast cancer surgery, as existing databases lack the specificity and detail of critical data elements that currently drive decisions for initial breast surgery We propose to develop a multicenter electronic breast cancer surgery outcomes database that will allow for an assessment of measures of surgical quality by examining variation in outcomes of initial breast cancer surgery. In addition, we will develop protocols and data capture tools that can be implemented elsewhere in order to extend this data network to future additional CRN sites. The development of such a clinical data network will allow comparative effectiveness research to be conducted, particularly as related to current controversies in the management of breast cancer, such as an appropriate pathologic margin of clearance in partial mastectomies. We believe this controversy currently results in tens of thousands of additional operations performed annually, lowering patient quality of life and at the cost of hundreds of millions of dollars, without specified impact on cancer recurrence or patient survival. Our development of a well designed cancer surgery outcomes database will allow for important clinical questions to be answered in a timely and cost-effective manner. PUBLIC HEALTH RELEVANCE: This application seeks to firmly establish measures of quality for initial breast cancer surgery. Improved understanding of surgical quality can potentially diminish wide variability in outcomes and healthcare costs associated with breast cancer surgery.

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Natural Language Processing for Cancer Research Network: Surveillance Studies Direct link to this project

Project Staff:
  • Project Leader: David Carrell, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2009

Area(s) of Research: Epidemiology & Surveillance; Informatics

Tumor Site(s): Breast

Phase(s) of Care: Screening; Diagnosis; Treatment

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This application addresses Broad Challenge Area: (10) Information Technology for Processing Health Care Data and specific Challenge Topic: 10-CA-107 Expand Spectrum of Cancer Surveillance through Informatics Approaches. The proposed project launches a collaborative effort to advance adoption within the HMO Cancer Research Network (CRN) of "industrial-strength" natural language processing (NLP) systems useful for mining valuable, research-grade information from unstructured clinical text. Such text is available for processing, now in the electronic medical record (EMR) systems of affiliated CRN health plans. The proposed NLP methods will create ongoing capacity to tap what has recently been described as "a treasure trove of historical unstructured data that provides essential information for the study of disease progression, treatment effectiveness and long-term outcomes" (5). The vision of advancing widespread NLP capacity across the CRN, as well as the approach we present here for implementing it, grew out of an in-depth strategic planning effort we completed in December 2008. That effort involved participants from six CRN sites guided by a blue-ribbon panel of NLP experts from three of the nation's leading centers of clinical NLP research: University of Pittsburgh Medical Center, Vanderbilt University, and Mayo Clinic. The vision is to deploy a powerful NLP system locally, manage it with newly hired and trained local NLP technical staff, and conduct NLP-based research projects initiated by local investigators, in consultation with higher-level external NLP experts. Our planning efforts suggest this collaborative model is feasible; we will test the model in the context of the proposed project. An important development in April 2009 yielded what we believe is a potentially transformative opportunity to accelerate adoption of NLP capacity in applied research settings: release of the open-source Clinical Text Analysis and Knowledge Extraction System (cTAKES) software. This software was the result of a collaborative effort between IBM and Mayo Clinic. Built on the same framework Mayo Clinic currently uses to process its repository of over 40 million clinical documents, cTAKES dramatically lowers the cost of adopting a comprehensive and flexible NLP system. Deployment and use of such systems was previously only feasible in institutions with large, academically-oriented biomedical informatics research programs. Still, other deployment challenges and the need to acquire NLP training for local staff present residual barriers to adopting comprehensive NLP systems such as cTAKES. In collaboration with five other CRN sites the proposed project mitigates these challenges in two ways: 1) it develops configurable open-source software modules needed to streamline and therefore reduce the cost of deploying cTAKES, and 2) it presents and tests a model for training local staff through hands-on NLP projects overseen by outside NLP expert consultants. The potential impact of this project is evident most clearly in the vast untapped opportunities for text mining represented in CRN-affiliated health plans, where EMR systems have been in place since at least 2005, and whose patients represent 4% of the U.S. population. Clinical text mining offers the potential to provide new or improved data elements for cancer surveillance and other types of research requiring information about patient functional status, medication side-effects, details of therapeutic approaches, and differential information about clinical findings. Another significant impact of this project is its plan to integrate into the cTAKES system an open-source de-identification tool based on state of the art, best of breed NLP approaches developed by the MITRE Corporation. De-identification of clinical text will make it easier for researchers to get access to clinical text, and will also facilitate multi-site collaborations while protecting patient privacy. Finally, if successful, the NLP algorithm we propose as a proof-of-principle project at Group Health-which will classify sets of patient charts as either containing or not containing a diagnosis of recurrent breast cancer-could dramatically reduce the cost of research in this area; currently all recurrent breast cancer endpoints must be established through costly manual chart abstraction. Novel aspects of the proposed project include its talented and transdisciplinary research team, including national experts in NLP, and its resourceful strategy for building the technical resources and "human capital" needed to support an ongoing program of applied NLP research. Natural language processing is itself a highly innovative technology; when successfully established in multiple CRN in the future it will represent a watershed moment in the CRN's already impressive history of exploiting data systems to support innovative research. Newly hired staff positions total approximately 2.0 FTE in each project year, most of which we anticipate will be supported by ongoing new research programs after the proposed project concludes. Project narrative The proposed project develops new measurement technologies for extracting information about disease processes and treatment, currently documented only in clinical text, based on natural language processing approaches. Because these methods are generic they will potentially contribute to public health by advancing research in a wide variety of areas. The "proof of principle" algorithm developed in the project to identify recurrent breast cancer diagnoses will advance epidemiologic and clinical research pertaining to the 2.5 million women currently living with breast cancer.

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SEARCH: Screening Effectiveness And Research in Community-based Healthcare Direct link to this project

Project Staff:
  • Project Leader: Chyke Doubeni, Meyers Primary Care Institute
  • Project Leader: Diana Buist, Group Health
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Azadeh Stark, Geisinger Health System
  • Investigator: Jessica Chubak, Group Health
  • Investigator: Kathryn Richert-Boe, KP Northwest
  • Investigator: Kenneth F Adams, HealthPartners Research Foundation
  • Investigator: Natasha Stout, Harvard Pilgrim Health Care
  • Investigator: Noel Weiss, University of Washington
  • Investigator: Robert T. Greenlee, Marshfield Clinic Research Foundation
  • Investigator: Sheila Weinmann, KP Northwest
  • Investigator: Terry Field, Meyers Primary Care Institute
  • Investigator: Theodore R. Levin, KP Northern California
  • Investigator: Thomas Vogt, KP Hawaii

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2009

Area(s) of Research: Epidemiology & Surveillance; Comparative Effectiveness

Tumor Site(s): Cervical; Colorectal

Phase(s) of Care: Screening

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Background

Improvements in cancer screening effectiveness, higher participation rates and faster introduction of new screening tests could have pronounced effects on the health of the community by reducing cancer burden. Cancer screening effectiveness in real-world settings depends not only on the efficacy of individual tests but also on patients, health care providers, and the systems and context in which health care is delivered. Large and well defined populations of enrollees with diverse data sources are fundamental for comparative effectiveness research that addresses health policy questions about cancer screening delivery.

Objective

In response to the Grand Opportunity (GO), we propose to create an innovative and sustainable multi-disciplinary and multi-institutional virtual center for cancer SEARCH: Screening Effectiveness And Research in Community-based Healthcare within the NCI-funded Cancer Research Network (CRN). Because SEARCH is set in CRN-affiliated health care delivery systems across the United States, it will benefit directly from the strong foundation of an existing and well-established network of NCI-funded research infrastructure. An innovative portion of SEARCH will be our ability to translate and disseminate of our findings directly into practice. We have identified and engaged a national Advisory Board of cancer screening experts and have proposed a new collaboration with the Cancer Intervention and Surveillance Modeling Network (CISNET). Together, we will pursue high priority comparative effectiveness research (CER) that has relevance to clinicians, patients, policy makers, payers, public health practitioners and medical associations.

Eight CRN sites will be involved in this application with four sites (Group Health, Kaiser Northwest and Hawaii, and Fallon) contributing data for the proof of principle studies. We expect SEARCH will serve as a productive platform for launching larger CER studies. During the two year funding period, we will build necessary infrastructure and collaborations, and will seek additional funding to address important questions on the quality and effectiveness of cancer screening care delivery in community-based health care systems.

Specific Aims

  1. Create a multi-disciplinary, multi-site team for CER focused on the delivery of cancer screening in community-based settings.
  2. Develop methodological capacity for future large-scale, population-based CER studies.
  3. Demonstrate our ability to conduct CER in the area of cancer screening to address important evidence gaps.

Public Health Relevance

Large and well defined populations of enrollees with diverse data sources are fundamental for comparative effectiveness research that addresses health policy questions about cancer screening delivery. We plan to study approaches to effectively deliver cancer screening to populations in order to enhance detection, diminish morbidity and other adverse effects, and ultimately reduce mortality. The SEARCH: Screening Effectiveness And Research in Community-based Healthcare research team will be based within the geographically diverse health care systems of the NCI-funded Cancer Research Network, which is a consortium of 14 health plans across the US, and will enable translation of our findings directly into clinical practice in community settings.

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Understanding Racial and Ethnic Differences in Survival from Colorectal Cancer Supplement Direct link to this project

Project Staff:
  • Project Leader: Chyke Doubeni, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 9/25/2009

Area(s) of Research: Epidemiology & Surveillance; Health Disparities

Tumor Site(s): Colorectal

Phase(s) of Care: Diagnosis; Treatment; Survivorship

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Background

Colorectal cancers are the third most common invasive cancers among men and women in the United States. Improvements in prevention, screening and treatment have resulted in decreasing case-fatality rates from colorectal cancer since the 1980s. Paradoxically, disparities in survival from this cancer especially between Blacks and Whites have widened over time. Although there is no consensus in existing literature, current evidence suggests that factors related to access to health care including socioeconomic differences contribute to these disparities. The goal of the proposed research program is to identify potentially modifiable causes of disparities in cancer survival with a long range goal of reducing or eliminating the disproportionate burden of colorectal cancer among certain patient populations.

Specific Aims

  1. Compare colorectal cancer survival rates by race/ethnicity over the period 1993 through 2004.
  2. Compare the distribution of tumor stage at diagnosis for colorectal cancer by race/ethnicity.
  3. Examine potential mediators of the relationship of survival and race/ethnicity among colorectal cancer patients.
  4. Examine the patterns of care of survivors of colorectal cancer
  5. Explore the effect of socioeconomic status on the relationship between race/ethnicity and survival among colorectal cancer patients.

Methods

This project will be conducted on a large racially diverse cohort comprised of patients 20 years and older diagnosed with colorectal cancer (1993 to 2004) while enrolled in one of four integrated health care systems that are affiliated with the National Cancer Institute-funded Cancer Research Network.

Significance

This research plan is part of a career development program aimed at providing the training and experience needed for Dr. Doubeni to become an independently funded clinician-investigator focusing on disparities in cancer survival. The objectives of the career development plan are to acquire knowledge and skills in: 1) cancer biology, epidemiology and treatment; 2) advanced research methods; 3) scientific writing; and 4) the translation of research into practice and policy. The career development program will be accomplished through mentoring and targeted advanced courses. The studies encompassed under the proposed research program will make important contributions to our understanding of racial/ethnic differences in cancer survival rates. The proposed project will lay the foundation for the candidate's long-term career goal of designing system-based interventions aimed at eliminating disparities in cancer care and survival, a major objective of HealthyPeople 2010.

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Development of an Online Dissemination Planning Tool Direct link to this project

Project Staff:
  • Project Leader: Borsika Rabin, KP Colorado
  • Investigator: James Dearing, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2009

Area(s) of Research: Dissemination & Diffusion

Phase(s) of Care: Prevention; Treatment

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Specific Aims:

  1. to develop an online dissemination planning tool to enhance the dissemination and widespread adoption of interventions and products emerging from effective cancer care and cancer prevention communication intervention research;
  2. to implement the online dissemination planning tool with the collaboration of the five CECCRs and 14 CRN institutions;
  3. to evaluate the online dissemination planning tool for usability in terms of format and content and in turn make this tool more broadly available.

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Electronic Data Transfer of Co-Morbidity and Related Data from CRN to the Hawaii Tumor Registry to Expand Spectrum of Surveillance Data – Pilot Study Direct link to this project

Project Staff:
  • Project Leader: Mark Hornbrook, KP Northwest
  • Investigator: Andrew Williams, KP Hawaii

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2009

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Colorectal

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This is a data sharing pilot study between KPH and the Hawaii Tumor Registry. KPH will be enhancing their tumor reporting with comorbidity data on its cancer patients for the period 2000-2008. This is a pilot test to develop the protocols and data processing procedures for adding comorbidity data to the SEER Registry. HTR SEER scientists will then conduct some descriptive analyses to evaluate the relationships among stage at diagnosis, comorbidity burden, and race/ethnicity for colorectal cancers.

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Medical Care Burden of Cancer: System and Data Issues Supplement Direct link to this project

Project Staff:
  • Project Leader: Mark Hornbrook, KP Northwest
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Paul Fishman, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2009

Area(s) of Research: Economics

Phase(s) of Care: Treatment

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The total medical costs of cancers are about 5% of national health care expenditures and 10% of Medicare outlays. Much of what we know about cancer costs comes from the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) cancer registries linked to Medicare claims (SEER- Medicare). While the SEER-Medicare link represents the experience of 85% of Aged Medicare beneficiaries enrolled in the fee-for-service (FFS) indemnity option, the link omits the experience of the 15% of seniors enrolled in Medicare HMOs. These groups differ: 1) HMO providers face different incentives; 2) HMO Medicare beneficiaries generally have better benefits; 3) given that FFS vs. HMO choice is voluntary, the 2 populations may differ in their health status and preferences in ways that are difficult to measure. In addition, utilization and costs for Medicare Working Aged beneficiaries may be under-reported in SEER-Medicare. These factors may cause selection and omission biases in cancer cost estimates based on ether group alone. Building on the Cancer Research Network, we will develop a multi-site, multi-payer database to support analyses extending and complementing the SEER-Medicare link by addressing 3 aims: Aim 1 - Descriptive Analyses: Estimate the incremental medical care cost of all cancers, and selected cancers, broken down by cancer site, phase of treatment, stage at diagnosis, cancer type (fatal vs. non- fatal), patient demographics, co-morbidity, and source of health insurance for the years 2000-2007 in 4 large integrated health care systems. Aim 2 - Omissions Bias: Estimate the costs of each cancer care component for Aged Medicare HMO beneficiaries that is omitted from SEER-Medicare: a) non-Medicare covered services; b) effects of health care for seniors whose cancers were diagnosed before age 65; c) cancer screening services; d) cancer prevention services; e) changes in benefits, if any, associated with switching from private health insurance to Medicare; and f) employer-covered benefits for Working Aged beneficiaries. Aim 3 - Selection Bias: Estimate the incremental medical care costs of all cancers, as well as selected cancers, for SEER-Medicare over 2000-2007. Model the determinants of cancer costs across HMO and FFS systems for Medicare Aged beneficiaries, correcting for selection and omissions biases. We hypothesize that HMO/FFS system differences, benefit differences, and omissions biases will account for a larger proportion of cancer costs that those from selection biases. This study will update the information on the medical care costs of cancer for Aged Medicare beneficiaries. We will also learn how cancer care varies between Medicare's FFS and HMO options.

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Childhood, Adolescent and Young Adult Cancer Survivors - CRN Feasibility Pilot Direct link to this project

Project Staff:
  • Project Leader: Sarah Greene, Group Health
  • Investigator: Andrea Altschuler, KP Northern California

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2009

Area(s) of Research: Outcomes

Phase(s) of Care: Survivorship

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Substantial advances in the treatment of childhood, adolescent, and young adult cancers mean that approximately 75% of individuals diagnosed with cancer as children, adolescents, or young adults will survive at least five years after their diagnosis. Ongoing monitoring of this growing population has led to the recognition that survivors experience adverse effects of their cancer and cancer treatment long after their treatment has ended. The Childhood Cancer Survivor Study has contributed enormously to our understanding of these adverse effects, yet is limited by a focus on a subset of cancers in those aged 20 years and younger; small numbers of minority group participants; lack of data on the first five years after cancer diagnosis; and use of self-reported outcomes. The populations and data resources of the Cancer Research Network present a unique opportunity to overcome these limitations. Therefore, our goal is to use the Virtual Data Warehouse to explore the feasibility of studying childhood, adolescent and young adult cancer survivors by confirming that cancer incidence from electronic data at two CRN healthcare delivery systems are comparable to national data and examining how long survivors can be followed in these systems. Specifically, for individuals diagnosed with cancer at age 39 years or younger from 1997 to 2006 while enrolled at Group Health or Kaiser Permanente Northern California, we aim to describe their: (1) demographic characteristics, tumor types, and treatments received and (2) pre- and post-cancer diagnosis enrollment patterns, including how they vary by demographic characteristics, tumor types, and treatments received. We will model our cohort study methods on those used by Terry Field and others in their study of adult cancer survivor retention in the CRN (JNCI 2004). This pilot data then will be incorporated into a R01 grant proposal to study patterns of first course of treatment, five year survival, late effects, and utilization among survivors of childhood, adolescent, and young adult cancers.

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Development of a Model for Predicting Prostate Cancer Direct link to this project

Project Staff:
  • Project Leader: Deanna Cross, Marshfield Clinic Research Foundation

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2009

Tumor Site(s): Prostate

Phase(s) of Care: Screening

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Project Description:

Rationale: Effective prostate cancer screening is important for the alleviation of prostate cancer. Unfortunately, the current screening techniques lack specificity and sensitivity leading to many negative biopsies and missing a number of clinically relevant cancers. While there is new information regarding the environmental and genetic risk factors for prostate cancer, to date, there has been no effort to incorporate this information into a comprehensive model for prostate cancer prediction to develop a more accurate screen.

Goal: Develop a multivariate model that predicts clinically relevant prostate cancer by incorporating known risk factors such as PSA and age along with the recently identified genetic and environmental risk factors.

Specific Aim 1: We will develop a multivariate model for prostate cancer detection in a simulated population. A simulated population of at least 100,000 screened individuals will be created. We will then assign the following characteristics to each individual: age, ethnicity, family history of prostate cancer, PSA value, genotype, and dietary intake of low fat dairy products. Using this simulated population we will construct a number of models using multivariate logistic regression to determine the minimal number of parameters that can be used to discriminate between prostate cancer and control subjects. Each of the models will be ranked according to predictive value sensitivity and specificity.

Specific Aim 2: We will determine if any of the models developed in the simulated population can be used to predict prostate cancer in a screened population. Using the Personalized Medicine Research Project (PMRP) we will validate the multivariate logistic regression model developed above. Currently there are 3,931 individuals in the PMRP cohort that have a PSA value, 1,178 who have had a biopsy, and 453 who have been diagnosed with prostate cancer. We have obtained completed dietary history information on approximately 2/3 of these individuals. We will determine the genotype of this population for 12 polymorphisms that have been associated with prostate cancer and. We will test the model for accuracy in this population and test for potential interactions between the known risk factors.

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Medical Radiation Induced Cancers Direct link to this project

Project Staff:
  • Project Leader: Diana Miglioretti, Group Health
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Laurie Habel, KP Northern California
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Michael Flynn, Henry Ford Health System
  • Investigator: Rebecca Smith-Bindman, University of California San Francisco
  • Investigator: Robert T. Greenlee, Marshfield Clinic Research Foundation

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2009

Area(s) of Research: Epidemiology & Surveillance

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The pilot project described in the application will allow the collaborative team to assemble preliminary data from the eight Cancer Research Network (CRN) sites needed to apply for a multi-site R01, with a schedule submission date of October 2009. In addition, the data collected will result in at least three manuscripts describing (1) patterns and variability of medical imaging over time, (2) patterns of radiation exposure associated with medical imaging over time, and (3) variation in radiation exposure associated with several common types of computed tomography (CT) examinations. The R01 will identify factors that contribute to variation in the utilization of medical imaging over time; will quantify variation in radiation dose associated with specific CT examinations and identify factors that contribute to this variation; and will empirically estimate the increased risk of radiation-sensitive cancers among patients associated with medical radiation exposure due to imaging.

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Preventing Errors in the Home Care of Children with Cancer Direct link to this project

Project Staff:
  • Project Leader: Kathleen Walsh, Meyers Primary Care Institute
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Kathleen Mazor, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2009

Area(s) of Research: Communication

Phase(s) of Care: Prevention

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Background: In our study of outpatient cancer care, we found pediatric medication errors were more common and more likely to occur at home than adult errors. Since our CRN pilot proposal last year, we have made several gains in our research agenda including developing a theoretical framework, publishing our home visit methods, and developing strategies to assess reliability and validity.

Objectives: 1) To investigate the validity and reliability of our home visit methods in measuring home medication errors in pediatric oncology; 2) To describe the prevalence of and characterize the types of home medication errors among children with cancer at two CRN sites; and 3) To conduct qualitative focus groups using a purposive sample of parents and healthcare providers of children with cancer to propose interventions to prevent home medication errors.

Methods: We will conduct 30 home visits to families of children with cancer on chemotherapy treated at UMass Memorial Medical Center and 30 at Kaiser Permanente Georgia. We developed a home visit method which includes four components: (1) observation of medication administration, (2) medication review, (3) in-depth parent interviews, and (4) physician review of possible errors- with methods to validate findings at each step. These proposed home visits will lead to our identifying the worst – most prevalent, most dangerous – errors and learning where things are going wrong. In 15 pilot visits to families of children with cancer we found 56 errors. Parent/provider focus groups will then use a modified Failure Modes and Effects Analysis to propose possible interventions to prevent home pediatric oncology errors.

Conclusions: The proposed two center study will characterize home errors in children with cancer and propose interventions to prevent these errors. At the completion of this study, we will be prepared to perform a randomized multicenter evaluation of these interventions within the CRN.

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HR-QOL in Colorectal Cancer Survivors with Stomas 2 Direct link to this project

Project Staff:
  • Project Leader: Robert Krouse, University of Arizona
  • Investigator: Lisa Herrinton, KP Northern California
  • Investigator: Mark Hornbrook, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 4/1/2009

Area(s) of Research: Psychosocial/Quality of Life; Survivorship Research

Tumor Site(s): Colorectal

Phase(s) of Care: Survivorship

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Specific Aim 1: To understand the determinants of outcomes in all long-term survivors of invasive rectal cancer and associated treatments, including those with (a) permanent ostomy, (b) anastomosis without temporary ostomy, and (c) anastomosis with temporary ostomy (indicating low cancers with minimal remaining rectum). Outcomes to be measured include bowel function, HR-QOL, work disability, and medical complications. Specific Aim 2: From among patients whose initial cancer surgery was anastomosis, to assess the relationships of tumor location, patient age, and co-morbidity on the rate of anastomotic failure and eventual permanent ostomy. Specific Aim 3: To better understand the scope of behavioral and dietary adjustments made by rectal cancer survivors with ostomy and anastomosis to control bowel function. Specific Aim 4: To collect qualitative data to more fully understand the lived experiences of minority rectal cancer survivors.

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Intestinal ostomies and informal caregiving for colorectal cancer survivors Direct link to this project

Project Staff:
  • Project Leader: Carmit McMullen, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 4/1/2009

Area(s) of Research: Psychosocial/Quality of Life

Tumor Site(s): Colorectal

Phase(s) of Care: Survivorship

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Many colorectal cancer survivors are living with intestinal ostomies, which can lead to bowel incontinence, unless managed daily with special equipment, diet, and behavior. Losing the ability to manage one’s ostomy independently can transform an ostomy from a manageable impairment to a source of profound disempowerment, stigma, and disability. This study, led by Dr. Carmit McMullen (KPNW), uses a social model of disability framework to better understand the interrelationships among disability and caregiving in this population, and identifies strategies that ostomates and their caregivers employ to cope with caregiving challenges. This study builds on a longstanding research program on the quality of life of long-term colorectal cancer survivors.

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Race, Treatment and Cardiovascular Health: A Study of Men with Prostate Cancer Direct link to this project

Project Staff:
  • Project Leader: Andrea Cassidy, Henry Ford Health System

Funding Source: Department of Defense
Funding Start Date: 4/1/2009

Area(s) of Research: Health Disparities

Tumor Site(s): Prostate

Phase(s) of Care: Treatment; Survivorship

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Few studies have examined racial differences in cardiovascular disease (CVD) in men with prostate cancer, although CVD is a leading cause of morbidity and mortality among men with prostate cancer. Androgen Deprivation Therapy (ADT) for prostate cancer is associated with CVD events in men with prostate cancer. Little is known, however, about the relationship between ADT, changes in CVD risk factor profiles and development of CVD events in minority populations, despite CVD risk being disproportionally distributed among racial minorities in the general population. We will establish a retrospective cohort of 2,000 Caucasian and African-American prostate cancer cases. We hypothesize that among these cases (1) African Americans compared to Caucasians will have more deleterious changes in their CVD risk profile and will experience more CVD events and (2) CVD risk factor changes and events will be most profound in men treated with ADT. This study may identify modifiable factors that could improve the health of prostate cancer survivors and reduce disparities in the survivorship of African-American men with prostate cancer relative to Caucasian men.

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CRN Cancer Communication Research Center Direct link to this project

Project Staff:
  • Project Leader: James Dearing, KP Colorado
  • Investigator: Adrianne Feldstein, KP Northwest
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Ed Wagner, Group Health
  • Investigator: Kathleen Mazor, Meyers Primary Care Institute
  • Investigator: Kathleen Walsh, Meyers Primary Care Institute
  • Investigator: Leif Solberg, HealthPartners Research Foundation
  • Investigator: Russ Glasgow, KP Colorado
  • Investigator: Sarah Greene, Group Health
  • Investigator: Tom Gallagher, University of Washington

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2008

Area(s) of Research: Communication; Quality of Care

Tumor Site(s): All

Phase(s) of Care: Prevention; Screening; Diagnosis; Treatment; Survivorship; End of Life

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The CRN Cancer Communication Research Center (CCRC) was funded by NCI in 2008 as a program project (P20) to advance research about cancer communication in clinical settings. Led by Dr. James Dearing (KPC), this is the first communication research center founded within the CRN. The Center identifies, tests, and applies optimal communication and coordination processes that facilitate patient-centered cancer care. Two initial core R01 projects are Testing an Optimal Model of Patient-Centered Cancer Care and Effective Communication for Preventing and Responding to Oncology Adverse Events. Eighteen investigators at eight CRN sites participate in the Center. The CCRC also ties the CRN into the Center of Excellence in Cancer Communication Research (CECCR) network of cancer communication research centers at Washington University, the University of Pennsylvania, the University of Michigan, and the University of Wisconsin. Through its shared resource cores that study and explore new practice-based approaches to cancer communication across the CRN as well as how to most effectively disseminate effective cancer communication interventions across clinical settings, the Center is heavily involved in translational research from the processes of innovation to the processes of replication and diffusion. Communication and care coordination processes are assessed across the cancer care continuum from prevention to early detection, diagnosis, treatment, survivorship, and end of life as well as across types, including breast, cervical, colorectal, lung, and prostate cancers.

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Effective Communication for Preventing and Responding to Oncology Adverse Events Direct link to this project

Project Staff:
  • Project Leader: Kathleen Mazor, Meyers Primary Care Institute
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Ed Wagner, Group Health
  • Investigator: Sarah Greene, Group Health
  • Investigator: Tom Gallagher, University of Washington

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2008

Area(s) of Research: Communication

Tumor Site(s): All

Phase(s) of Care: Treatment

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Background

Effective patient-provider communication is essential for high quality healthcare, and involves both preventing lapses in quality from occurring and responding to adverse events and medical errors when they happen. Effective communication with patients is especially challenging in oncology where communication breakdowns lead directly to adverse events or errors, such as when confusing instructions impair patients’ adherence to chemotherapy.

Specific aims

  1. To describe patients’ experiences with communication around adverse events and errors in cancer care.
  2. To describe providers' experiences with communication around adverse events and errors in cancer care.
  3. To develop practical recommendations, provider training materials and patient informational materials for improving communication around adverse events and errors in cancer care.
  4. To disseminate the recommendations and materials (Aim 3) through three health plans.
  5. To conduct a preliminary evaluation of the perceived usefulness and impact of the materials.

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Testing an Optimal Model of Patient-Centered Cancer Care Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Evette Ludman, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 9/30/2008

Area(s) of Research: Dissemination & Diffusion; Quality of Care

Phase(s) of Care: Diagnosis; Treatment

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The goal of this study is to develop an Oncology Nurse Care Management program for newly diagnosed breast, colorectal, and lung cancer patients that will address patient questions, symptoms, and psychosocial needs, and facilitates timely, coordinated care. Led by Dr. Edward Wagner (GHC), the study team will develop an early notification system of cancer diagnosis using automated data; develop and implement the case management system; and test its effectiveness in improving patient quality of care, psychosocial distress, and depression. This innovative care management program to enhance patient-centered care will help to fill an important gap in efforts to improve quality of cancer care surrounding diagnosis and treatment decision making.

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Long-Term Survivorship in Older Women with Early Stage Breast Cancer Direct link to this project

Project Staff:
  • Project Leader: Rebecca Silliman, Boston University Medical Center
  • Investigator: Ann Geiger, Wake Forest University
  • Investigator: Diana Buist, Group Health
  • Investigator: Feifei Wei, HealthPartners Research Foundation
  • Investigator: Heather Gold, Cornell University
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Reina Haque, KP Southern California
  • Investigator: Sharon Hensley Alford, Henry Ford Health System
  • Investigator: Soe Soe Thwin, Boston University Medical Center
  • Investigator: Terry Field, Meyers Primary Care Institute
  • Investigator: Timothy L. Lash, Boston University Medical Center
  • Investigator: Virginia Quinn, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 9/10/2008

Area(s) of Research: Epidemiology & Surveillance; Health Disparities; Quality of Care

Tumor Site(s): Breast

Phase(s) of Care: Survivorship

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Background

Earlier diagnosis, improved treatment, and the overall increase in longevity in later life continue to expand the number of breast cancer survivors who are 65+ years of age, already estimated to be one million (43%)of the total 2.3 million breast cancer survivors. This group of older breast cancer survivors represents 17% of all older cancer survivors, yet the impact of breast cancer and its treatment on survivorship is poorly understood. The parent study(Breast Cancer Treatment Effectiveness in Older Women - BOW I) studied 1859 women 65+ years of age with early stage breast cancer and provided strong evidence that variations in care have substantial consequences for older women: less-than-standard treatment is associated with increased rates of recurrence and breast cancer-specific mortality, while mammography surveillance during the first 5 years after diagnosis is associated with a reduced rate of breast cancer mortality. However, little

is known about the effectiveness of mammography surveillance for recurrence and second primaries beyond five years; the cost implications associated with short-term and long-term survivorship care; and the risk of late treatment effects. Responding to the survivorship research priorities of the National Cancer Institute (NCI) and the Institute of Medicine (IOM) to understand and reduce the adverse effects of cancer treatment in older adults, this renewal project (BOW II) will collect additional information about the BOW I breast cancer cohort through 15 years after diagnosis. A comparison cohort of women without breast cancer will be enrolled and matched on age, study site, and breast cancer diagnosis year that will be followed for the same period of time. We will characterize the survivorship of older breast cancer patients and in relation to a comparison cohort cared for in integrated health care systems through the efficient collection of data from medical records and electronic sources. This uniquely detailed dataset, collected by

an experienced interdisciplinary team of investigators, will provide new knowledge in three domains of survivorship research: follow-up care, health care costs, late effects of treatment. Both BOW I and II take advantage of the resources of the recently renewed Cancer Research Network (CRN).

Specific aims

  1. To determine whether surveillance mammography beyond 5 years following diagnosis reduces breast cancer-specific mortality, and explore whether surveillance mammography is cost-effective.
  2. To determine the cost-effectiveness of standard primary tumor therapy (breast conserving surgery [BCS] followed by radiation therapy or mastectomy) and adjuvant (tamoxifen) therapy, compared with less-thanstandard therapy, for older women with breast cancer.
  3. To identify late effects of breast cancer and its treatment by comparing incident comorbidity in 5-year breast cancer survivors to a matched comparison cohort without breast cancer.

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Building a Population Laboratory for Pharmacoepidemiologic and Pharmacogenomic Studies in Cancer: Cardiotoxicity following Systemic Therapy for Breast Cancer Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Adedayo A. Onitilo, Marshfield Clinic Research Foundation
  • Investigator: Alan Go, KP Northern California
  • Investigator: Catherine A. McCarty, Marshfield Clinic Research Foundation
  • Investigator: David Magid, KP Colorado
  • Investigator: Diana Buist, Group Health
  • Investigator: Erin Aiello Bowles, Group Health
  • Investigator: Heather Feigelson, KP Colorado
  • Investigator: Katrina Goddard, KP Northwest
  • Investigator: Larissa Nekhlyudov, Harvard Pilgrim Health Care
  • Investigator: Laurie Habel, KP Northern California
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Robert Davis, KP Georgia
  • Investigator: Sharon Hensley Alford, Henry Ford Health System
  • Investigator: Tom Delate, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 9/1/2008

Area(s) of Research: Epidemiology & Surveillance; Health Services; Methods

Tumor Site(s): Breast

Phase(s) of Care: Treatment; Survivorship

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This CRN proposal represents the collaborative efforts of four multicenter efforts involving members of the HMO Research Network (HMORN)—the AHRQ-funded HMORN Center for Education and Research in Therapeutics (CERTs), the NHLBI-funded Cardiovascular Research Network (CVRN), the Pharmacogenomics Scientific Interest Group of the HMORN, and the CRN. These networks contribute to and use a common data infrastructure. This project, led by Dr. Edward Wagner (GHC), is creating a population research laboratory to conduct pharmacoepidemiologic and pharmacogenomic studies, and will use this laboratory to examine important questions about the cardiotoxicity of systemic agents used to treat invasive breast cancer. Capacity development will assess the validity of electronic data on chemotherapy infusion; adapt and test alternative strategies for identifying cardiotoxicity using VDW data or other electronic data; explore the feasibility of strategies for assembling biological specimens and collecting DNA samples on study subjects; and add analytic variables for chemotherapy dose, route, and type and cardiotoxicity outcomes data to improve the VDW among the eight participating HMORN sites.

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High Deductible Health Plans and Receipt of Cancer Prevention Services Direct link to this project

Project Staff:
  • Project Leader: Doug Roblin, KP Georgia
  • Investigator: Adrianne Feldstein, KP Northwest
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Michael Maciosek, HealthPartners Research Foundation
  • Investigator: Paul Fishman, Group Health
  • Investigator: Richard Meenan, KP Northwest

Funding Source: American Cancer Society
Funding Start Date: 7/1/2008

Area(s) of Research: Economics; Health Services

Tumor Site(s): Breast; Cervical

Phase(s) of Care: Prevention

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The overall objective of this study is to examine the influence of enrollment into high deductible health plans on likelihood of being up-to-date on cancer screening and prevention services (screening mammograms, Pap tests, and HPV vaccinations) compared to enrollment in traditional HMO plans among age-eligible women. Analysis uses a quasi-experimental design in which age-eligible women enrolled in a high deductible plan are propensity score matched with age-eligible women enrolled in a traditional HMO plan. The overall working hypothesis is that enrollment in a high deductible plan will decrease the likelihood of being up-to-date on one or more of these services either directly or indirectly as a consequence of the higher levels of patient cost-sharing compared to traditional HMO plans. Two Kaiser Permanente (KP) regions -- KP Colorado and KP Georgia -- are participating in the study. The study covers the period 2000-2007 for screening mammogram and Pap tests and 2006-2009 for HPV vaccinations.

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Chemotherapy and Coinsurance: The Effect of Cost Sharing on Cancer Care Direct link to this project

Project Staff:
  • Project Leader: Debra Ritzwoller, KP Colorado
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Tom Delate, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: Economics; Health Services; Policy

Tumor Site(s): Breast; Colorectal; Lung

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Dr. Debra Ritzwoller (KPC) is leading this multiyear, multisite CRN pilot study to assess the impact of coinsurance on receipt of cancer chemotherapy services among breast, colorectal, and lung cancer patients. This observational study will compare the rates of chemotherapy regimen use for a cohort of HMO cancer patients, before and after the implementation of 20% coinsurance on all infused chemotherapy services, at one of the sites. This study will leverage the ongoing efforts of the CRN VDW chemotherapy working group, and it is an unparalleled opportunity for the CRN to help inform policymakers of the potential impact of cost–sharing changes on cancer care. Given the potentially large economic and clinical consequences of new cancer therapies and greater patient cost-sharing requirements, this study will inform our understanding of how these changes may impact cancer treatment, compliance, outcomes, and costs.

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Development of a Versatile Geospatial Database within the CRN Direct link to this project

Project Staff:
  • Project Leader: Andrea Cook, Group Health
  • Investigator: Tracy Onega, Dartmouth College
  • Investigator: Xun Shi, Dartmouth College

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: Informatics

Tumor Site(s): Breast

Phase(s) of Care: Treatment

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Geographic information associated with health records and facilities has a broad range of applications, including calculation of geographic access to health services, examination of service areas for health care systems, and measurement of geographically-based exposures. This project, led by Dr. Andrea Cook (GHC) and Dr. Tracy Onega (Dartmouth Medical School), will expand existing geocoding infrastructure to create a versatile geospatial database that will include individual, demographic, and facility-level geographic variables. The geocoded facility and member data will be used to examine the influences of travel time to facility, facility availability, and socioeconomic indicators on receipt of surveillance mammography.

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Media Coverage and Direct-to-Consumer Advertising of Genetic Tests Direct link to this project

Project Staff:
  • Project Leader: Alanna Rahm, KP Colorado
  • Investigator: James Dearing, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: Genetics; Health Services

Description: minus sign Hide

Background

Family history and genetic discoveries currently saturate the media. In addition, funding opportunities are increasingly offered to translate new genomic discoveries into the clinics or to test the integration of family history collection as a first step towards genetic testing in order to meet the NIH Roadmap for the 4P’s (Predictive, Personalized, Preemptive, and Participatory Medicine). Health Plans are in critical need of reliable information and education to help providers and patients understand the uses and implications of genetic tests as more become available and marketed directly to these end-users.

This exploratory study will begin to address these needs at Kaiser Permanente Colorado (KPCO) and will provide crucial background data that can be leveraged by the Cancer Research Network (CRN) Family History SIG in the development of RO1 applications to respond quickly to upcoming funding opportunities.

Specific aims

  1. To conduct a media analysis to determine number, polarity (positive or negative), and target audience of information about genetic tests and family history collection presented in the media over a one-year time period.
  2. To conduct focus groups with KPCO members, primary care, and specialty care providers, to elicit their knowledge, beliefs and attitudes about the specific genetic tests identified in Aim 1, and the use of family history information as a tool to assess disease risk.
  3. With the CRN Family History SIG, leverage the data from Aims 1 and 2 to develop and submit a multi-site RO1 no later than January 2010.

Significance

Through this exploratory work, the foundation will be built for additional research collaborations within the CRN and the Family History SIG to further study the knowledge, attitudes and beliefs about genetic testing and family history across multiple institutions and settings. This study will also address the immediate need for pilot data necessary for intervention studies that are crucial to thoughtfully train and educate patients and providers to make informed decisions about the utility and promise of family history and genomic medicine across those sites. This study will illuminate what is communicated to the public through media about the use of genetic testing and family history for genetic risk, and will provide a qualitative baseline level of the knowledge, attitudes and beliefs of patients and providers. This information will form the foundation for additional studies on decision-making, dissemination, and translation of genomic tests that are rapidly entering the healthcare environment.

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Opportunistic Colorectal Cancer Screening: Providing FIT with Annual Flu Shots Direct link to this project

Project Staff:
  • Project Leader: Carol Somkin, KP Northern California
  • Investigator: Michael Potter, University of California San Francisco

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: Epidemiology & Surveillance; Health Services

Tumor Site(s): Colorectal

Phase(s) of Care: Screening

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Background

Colorectal cancer (CRC) is preventable or curable when detected early, but, because screening is underused, it remains the second leading cause of cancer death in the US. One CRC screening method is with fecal immunochemical testing (FIT), a simple and inexpensive annual home test that is recommended for patients age 50 and older. Preliminary studies indicate that many individuals who get annual flu shots have not had or are not up to date with CRC screening.

Specific aims

  1. To determine whether offering FIT in the context of HMO-sponsored flu vaccine campaigns is an effective method to increase CRC screening activities among adults aged 50 and older
  2. To develop time-efficient, cost-effective, sustainable, nurse-driven systems to support the provision and completion of annual FIT.

Methods

The project will take place at Kaiser Permanente Santa Clara (KPSCL), a facility which annually provides flu shots to about 50,000 adults over age 50, approximately 20,000 of whom are typically overdue for colorectal cancer screening. The researchers will work with KPSCL personnel to develop procedures to assess patient eligibility for CRC screening during flu vaccine clinics using computerized medical records, develop trainings to support KPSCL staff to offer FIT during flu vaccine clinics, develop multilingual patient education materials and FIT instructions, and use these resources to implement a "FLU-FIT" campaign for KPSCL in the fall of 2008.

Significance

These activities will provide critical experience, data, and materials to support successful grant proposals to the American Cancer Society or National Cancer Instutute to study the reach, efficacy and overall robustness of "FLU-FIT" campaigns when disseminated and implemented in other Kaiser Permanente or HMO Cancer Research Network settings. This project will develop a system to use annual flu shot clinics as an opportunity for nurses to identify and offer annual CRC screening with FIT to eligible adults. The success of this project and its widespread application in other clinical settings could lead to greater access to CRC screening for millions of Americans, with improved cancer-related health outcomes for thousands who receive early diagnosis and treatment.

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Socioeconomic Diversity in Integrated Healthcare Delivery Systems Direct link to this project

Project Staff:
  • Investigator: Chyke Doubeni, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: Health Disparities

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Background

Persons of lower socioeconomic status (SES) are at higher risk for death from a wide variety of causes including cancer and pneumonia. However, there is currently conflicting evidence on SES health disparities due in part to a paucity of SES in the United States. Area-based SES measures (ABSM) can be obtained by linking subject addresses to the SES structure for specified areas as defined by the US Census Bureau. ABSMs are a relatively inexpensive way to obtain SES information. The Cancer Research Network (CRN) has the capability to further link ABSMs to claims data on large numbers of patients over lengthy periods of follow-up for intervention studies aimed at eliminating health disparities.

Objective

A major goal of this proposed project is to demonstrate the functionality of the virtual data warehouse (VDW) for studies using ABSMs and determine which ABSM indicators provide consistent differences in health care utilization in the CRN.

Specific Aims

The specific aims for this project are to determine among enrollees of 3 CRN sites:

  1. The distribution of area-level SES characteristics
  2. Differences in cancer screening rates by area-level SES
  3. Differences in pneumococcal vaccination rates by area-level SES.

Methods

We will use the CRN VDW to establish a large cohort of men and women aged 50 years or older, enrolled in one of 3 CRN sites between 2000 and 2001. This project will use diagnoses and procedure codes in the VDW utilization data to track participants over a 7-year period (2000-2006). Within this cohort, we will assess the distribution of various ABSM indicators based on the 2000 census SES structure and determine differences in rates of cancer screening and pneumococcal vaccination by SES. We will determine which ABSM indicators provide consistent differences in health care utilization.

Significance

Reducing death from cancer is a key US public health objective towards the goal of eliminating health disparities by 2010. This project will determine the potential of using SES information derived from the Census Bureau linked to patient addresses to identify and target vulnerable population for enhanced delivery of services.

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Health Literacy and Cancer Prevention: Do People Understand What They Hear? Direct link to this project

Project Staff:
  • Project Leader: Kathleen Mazor, Meyers Primary Care Institute
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Elizabeth Dugan, Meyers Primary Care Institute
  • Investigator: Mary Costanza, Meyers Primary Care Institute
  • Investigator: Melissa Finucane, University of Hawaii
  • Investigator: Sarah Greene, Group Health
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: Communication; Behavior

Phase(s) of Care: Prevention

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This study, led by Dr. Kathy Mazor of the University of Massachusetts, is developing a test of comprehension of oral (i.e., spoken) messages about cancer prevention and screening. Current measures of health literacy involve comprehension of written material, which is not how most key health information is transmitted. The team will examine the relationship between health literacy and cancer prevention using both quantitative and qualitative methods. Findings will lay the foundation for future research into the prevalence of inadequate oral health literacy, identification of groups and individuals with inadequate comprehension skills, and identification of risk factors and causes of limited comprehension. The project will develop recommendations for modifying oral messages so that they are easily comprehensible, and will test the impact of specific enhancements in a randomized experiment.

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Infrastructure: Cancer Research Network Across Healthcare Systems Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Azadeh Stark, Geisinger Health System
  • Investigator: Bert Davis, Lovelace Clinic Foundation
  • Investigator: Cheri Rolnick, HealthPartners Research Foundation
  • Investigator: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Larry Kushi, KP Northern California
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Robert T. Greenlee, Marshfield Clinic Research Foundation
  • Investigator: Suzanne Fletcher, Harvard Pilgrim Health Care
  • Investigator: Terry Field, Meyers Primary Care Institute
  • Investigator: Virginia Quinn, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2008

Area(s) of Research: n/a

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The HMO Cancer Research Network (CRN) was established in 1999 to help the National Cancer Institute maximize the potential of health care delivery systems to address important questions in cancer prevention and control. The CRN consists of an infrastructure and five projects with cover the spectrum of cancer control from prevention to survivorship. Our infrastructure leverages the unique composition and features of the health care delivery systems that comprise this consortium; the 13 health care systems that comprise the CRN consortium are distinguished by their mature automated data systems, commitment to public domain research, and diverse populations. The proposed application is designed to build on the productive cancer research consortium that was established and grown between 1999 and 2006. In this application, we propose to intensify and enhance CRN infrastructure activities that are uniquely positioned to address as yet unsolved issues in cancer care, including: 1) fulfilling the promise of health care informatics to optimize cancer care; 2) improving accrual of adult cancer patients to clinical trials; and 3) understanding the drivers which influence the uptake of innovations in cancer care. The proposed CRN infrastructure will emphasize efficient research methods, identify strategies that contribute to high-quality care, and will maintain a patient-centered perspective. Moreover, with a concerted focus on training of junior investigators, the HMO CRN will utilize the human and technical resources available in its health care systems, to permit exploration and exploitation of ways to improve effectiveness of cancer care. Cancer is a very individual experience. We need ways to address both the impact of cancer at a population level, and ways to help individual patients get the care that is best-suited to their unique needs. To this end, the CRN is designed to increase our understanding of the patient-, clinician- and health plan characteristics that lead to the best possible outcomes in cancer prevention and care.

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cancer Biomedical Informatics Grid (caBIG) Participation Contract Data Sharing and Intellectual Capital Workspace Task Order 1 Direct link to this project

Project Staff:
  • Project Leader: Sarah Greene, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 3/7/2008

Area(s) of Research: Informatics

Description: minus sign Hide

The major goals of this contract are 1) to contribute to the identification and resolution of regulatory and proprietary issues inherent in sharing research data, biospecimens, and other intellectual products; 2) participate in ongoing examinations of best practices or similar guidance which have the potential to assist the research community in navigating data sharing issues; 3) collaborate with other participants on the development of white papers, tools and other products that facilitate data sharing.

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cancer Biomedical Informatics Grid (caBIG) Participation Contract Population Sciences Task Order 2 Direct link to this project

Project Staff:
  • Project Leader: Sarah Greene, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 3/7/2008

Area(s) of Research: Informatics

Description: minus sign Hide

The overall objective of this project is to contribute to the mission of the Cancer Biomedical Informatics Grid (caBIG™) initiative, which is a large-scale endeavor of the National Cancer Institute to connect the cancer research community through an enhanced informatics, tools, and infrastructure. Specifically, the Population Sciences Special Interest Group (SIG) aims to advance the various disciplines of population sciences including Epidemiology, Surveillance, Behavioral Science, Prevention, Cancer Control, Biostatistics, Cohort Studies, and Health Outcomes Research by creating data standards and developing tools that operate within caBIG™ and leveraging existing caBIG™ activities and resources to address the common needs of these disciplines.

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Developing a Distributed Research Network to Conduct Population-Based Studies and Safety Surveillance (DRN Phase 1) Direct link to this project

Project Staff:
  • Project Leader: Rich Platt, Harvard Pilgrim Health Care
  • Investigator: David Magid, KP Colorado
  • Investigator: Ed Wagner, Group Health
  • Investigator: Jeff Brown, Harvard Pilgrim Health Care
  • Investigator: Joe Selby, KP Northern California
  • Investigator: Patrick O'Connor, HealthPartners Research Foundation
  • Investigator: Robert Langer, Geisinger Health System
  • Investigator: Sean Hennessey, University of Pennsylvania

Funding Source: Agency for Healthcare Research and Quality
Funding Start Date: 9/25/2007

Area(s) of Research: Methods; Comparative Effectiveness

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The DEcIDE Network focuses primarily on comparative effectiveness of therapies to generate new knowledge quickly, with emphasis on areas of interest to CMS. The HMORN CERT was awarded a DEcIDE center contract in 2005 as part of AHRQ’s Effective Health Care program, which offers 6–10 task orders per year.

The DEcIDE Network includes all 15 HMORN sites, and to date, has been awarded six DEcIDE task orders totaling over $5 million.

The most recent award, a pilot to develop a Distributed Research Network to conduct population-based studies and safety surveillance, will advance the HMORN’s ability to conduct multi-site study by leveraging existing infrastructure, such as the VDW, and prototyping a scalable distributed network.

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Understanding Racial and Ethnic Differences in Survival from Colorectal Cancer Direct link to this project

Project Staff:
  • Project Leader: Chyke Doubeni, Meyers Primary Care Institute
  • Investigator: Robert Fletcher, Harvard Pilgrim Health Care
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 9/1/2007

Area(s) of Research: Health Disparities

Tumor Site(s): Colorectal

Phase(s) of Care: Screening; Diagnosis; Treatment

Description: minus sign Hide

Background

Despite improvements in overall case-fatality rates over the past two decades, disparities in survival from colorectal cancer particularly between Blacks and Whites have continued to increase. The causes of these disparities remain unclear. Given that colorectal cancer is preventable and potentially curable, it is imperative to identify the underlying causes of racial and ethnic differences in survival. The goal of this proposal is to identify potentially modifiable contributing factors to disparities in survival from colorectal cancer that may be amenable to system-based interventions.

Few studies have examined outcomes for colorectal cancer in racially diverse populations with health insurance coverage. Cancer Research Network-affiliated health care systems have stable enrolled racially and geographically diverse populations from varying socioeconomic backgrounds including patients younger than 65 years. These settings provide a unique laboratory in which to examine influences on colorectal cancer survival that are independent of the effects of health care insurance.

Study Aims

The specific aims of this proposed project are to:

  1. Compare colorectal cancer survival rates by race and ethnicity over the period 1993 through 2004.
  2. Compare the distribution of tumor stage at diagnosis for colorectal cancer by race and ethnicity.
  3. Examine potential mediators of the relationship between race/ethnicity and survival among colorectal cancer patients, including:

a) Patterns of colorectal examinations before cancer diagnosis

b) Patterns of cancer-directed therapy after cancer diagnosis

c) Burden of chronic medical conditions around the time of diagnosis.

  1. Examine the patterns of care of survivors of colorectal cancer.
  2. Explore the influence of socioeconomic status on the relationship between race/ethnicity and survival among patients with colorectal cancer.

Methods

This proposed project will be conducted on a large multi-racial cohort of patients diagnosed with carcinoma of the colon and rectum between 1993 and 2005 while enrolled at one of 4 health care systems affiliated with Cancer Research Network, by expanding the current Cancer Research Network racial disparities dataset. The sites have been selected to include those affiliated with health care systems with relatively large proportions of non-White members. Colorectal cancer patients will be identified through the sites’ electronic tumor registries and linked to information in electronic administrative databases. Within this cohort, the influence of race/ethnicity on stage at diagnosis and survival and examine potential mediators of survival disparities we will quantify.

Significance

This proposal will improve the understanding of racial disparities by examining aspects of the clinical care of patients with colorectal cancer that may contribute to disparities, including patterns of use of emerging technologies.

Project Status

This is an NCI mentored career development project and Chyke Doubeni, MD, MPH is PI. The PI is mentored by several senior investigators within and outside the Cancer Research Network including Dr. Terry Field and Robert Fletcher. Dr. Doubeni is currently working with a variety of data from several sources including the NIH-AARP study, MCBS, NHIS, the US Census Bureau, Area resources File (AHRQ) Qualitative Data from key informants, and PLCO. Manuscripts are currently being developed around the incidence and mortality from CRC, the use of CRC screening services.

This is a cross-cutting project that involves primary data collection, studies of the effectiveness of cancer screening, and the use of cancer prevention services. Dr. Doubeni also conducts research on youth tobacco research under the auspices of this career development program focused on the influence of environmental factors on smoking initiation.

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Medical Care Burden of Cancer: System and Data Issues Direct link to this project

Project Staff:
  • Project Leader: Mark Hornbrook, KP Northwest
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Paul Fishman, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2007

Area(s) of Research: Economics; Health Services

Tumor Site(s): All

Phase(s) of Care: Treatment

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Most cancer cost estimates are from the NCI's SEER cancer registries linked to Medicare claims (SEER-Medicare). These data only represent the experience of the more than 80% of aged Medicare beneficiaries enrolled in the fee-for-service (FFS) indemnity option; no information is available about the remaining seniors enrolled in Medicare HMOs. In addition to differences in patient benefits, HMO providers face different incentives, and because beneficiaries select their coverage, the populations may differ in their health status and preferences in ways that are difficult to measure. These factors may cause selection and omission biases in cancer cost estimates based on either group alone.

This project, led by Dr. Mark Hornbrook (KPNW), will extend and complement the SEER-Medicare link by (1) estimating the incremental medical care cost of all cancers by cancer site, stage at diagnosis, patient demographics, and source of health insurance (FFS vs. HMO); (2) estimating costs of non-Medicare covered services; and (3) modeling the determinants of cancer costs across HMO and FFS systems, correcting for selection and omissions biases. The study team received an NCI supplement to estimate the costs of cancer care in the non-elderly population. Additionally, Dr. Hornbrook is leading the study team with a pilot study to estimate the cancer-related pharmacy costs among aged Medicare HMO beneficiaries that are not covered in FFS Medicare. A byproduct of this body of research will be the development of a reusable infrastructure that will enhance the CRN VDW for other uses, including efforts focused on the dissemination of pharmacotherapy among cancer patients over time.

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Economic Burden pilot study Direct link to this project

Project Staff:
  • Project Leader: Mark Hornbrook, KP Northwest
  • Investigator: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Paul Fishman, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 6/22/2007

Area(s) of Research: Economics; Health Services

Phase(s) of Care: Treatment

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This two-year infrastructure pilot study will use data from four sites to estimate the cancer-related pharmacy costs among aged Medicare HMO beneficiaries who were omitted from SEER-Medicare data due to the exclusion of outpatient medication use/cost. The investigative team will test the hypothesis that SEER-Medicare data undercount the full economic burden of cancer care in the U.S., because of incomplete coverage of outpatient prescribed medications for aged Medicare beneficiaries. A byproduct of this research will be the development of a reusable infrastructure that will enhance the CRN VDW for other uses, including efforts focused on the dissemination of pharmacotherapy among cancer

patients. This pilot study complements the R01 project, Medical Burden of Cancer: System and Data Issues.

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Cancer Prevention Index Direct link to this project

Project Staff:
  • Project Leader: Thomas Vogt, KP Hawaii
  • Investigator: Mark Hornbrook, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2007

Area(s) of Research: Epidemiology & Surveillance; Health Services

Tumor Site(s): Breast; Cervical; Colorectal; Prostate

Phase(s) of Care: Prevention

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This two-year pilot study, led by Dr. Thomas Vogt (KPH), will use the Prevention Index methodology and the CRN VDW to develop and apply a set of Cancer Prevention Index (CPI) metrics to assess the quality of primary and secondary preventive care for cancer. The study will identify the variation in CPI scores across clinics and practices, determine the association of these variations with selected event rates several years later, and evaluate the association of clinician adherence to guidelines with subsequent events among their patients. The study will assess the CPI for secondary prevention (i.e., screening for breast, cervical, colorectal, and prostate cancers) and relate this index to stage at diagnosis, survival, and medical care utilization with 5- and 10-year follow-up for all persons by practice-level performance. A complementary CPI study that incorporates preventive practices relevant to cardiovascular disease was recently funded as part of the HMO Cardiovascular Research Network (HMOCVRN), sponsored by the National Heart, Lung, and Blood Institute.

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Increasing Patient Participation in Clinical Trials Direct link to this project

Project Staff:
  • Project Leader: Carol Somkin, KP Northern California
  • Investigator: Ed Wagner, Group Health
  • Investigator: Sarah Greene, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 5/1/2007

Area(s) of Research: Health Services

Phase(s) of Care: Treatment

Description: minus sign Hide

This study is also called CHOICES: Understanding Clinical Trials as a Treatment Option.

Other sites involved are: Group Health Cooperative, Kaiser Permanente Southern California, Kaiser Permanente Colorado.

Background

Clinical trials are the primary mechanism by which new approaches to cancer treatment can be evaluated, yet only a very small proportion of eligible cancer patients are offered the opportunity to participate in clinical trials, and fewer actually enroll.

Specific aims

  1. Evaluate in a cluster randomized trial the effectiveness of a telephone counseling intervention to increase enrollment in cancer clinical trials, as well as knowledge about clinical trials and satisfaction with treatment decision. The intervention will be tailored to patient language (English and Spanish), ethnic and cultural background, knowledge, attitudes and beliefs about clinical trials.
  2. Assess where in the clinical trials recruitment process the greatest proportion of patients are lost to enrollment and develop estimates—by age, gender, and race/ethnicity—of the proportion of potentially eligible patients who are offered and who enroll in clinical trials.
  3. Determine the most strategic places in the recruitment process for future interventions to improve recruitment to cancer clinical trials.

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Residential segregation, housing status and prostate cancer in African American and white men Direct link to this project

Project Staff:
  • Project Leader: Christine Neslund-Dudas, Henry Ford Health System

Funding Source: Department of Defense
Funding Start Date: 4/1/2007

Area(s) of Research: Health Disparities

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Background

African American men have considerably higher incidence of prostate cancer and mortality due to the disease compared to white men in the United States. After much research, however, race, age, family history of the disease and living in a western nation still remain the only consistently reported risk factors for the disease. Social science suggests that race-based residential segregation may be a fundamental cause of racial disparities in health. Segregation affects education, employment, health care, and housing quality. Poor housing conditions have been known to affect health for more than 100 years but have not been studied in regard to prostate cancer risk, although housing differs substantially for African American and white men. Therefore, we hypothesize, that race-based residential segregation leads to disparities in both area (census tract/block group) and individual physical and social housing conditions that dispose African American men to differential environmental conditions that lead to excesses in biological damage, increasing risk for prostate cancer, earlier age of prostate cancer onset, and worse prostate cancer outcomes.

Study Aims

  1. To determine whether selected area housing and individual housing status (homeownership, housing density, and other housing factors such as age of structure and heating sources) are associated with prostate cancer risk, age at diagnosis, and tumor aggressiveness and whether housing status is associated with observed racial differences in these prostate cancer outcomes.
  2. To determine, through the use of factor analysis, whether area housing and individual housing status, is associated with prostate cancer risk, age at diagnosis, and tumor aggressiveness, through “latent factors” that include diet, physical activity, and genetic polymorphisms and whether those “latent factors” differ by race.
  3. To begin to test biological pathways through which housing status may impact prostate health outcomes; specifically, whether housing status is associated with markers of DNA damage (polycyclic aromatic hydrocarbons DNA-adducts (PAH)) and DNA stability (telomere content) in prostate tumor tissue and tumor-adjacent normal tissue of African American and white cases.

Methods

The study which is funded by the Department of Defense Prostate Cancer Research Program (PI: Christine Neslund-Dudas) is a secondary data analysis of previously enrolled prostate cancer cases and controls accrued for a gene-environment interaction study originally funded by the National Institute of Environmental Health Sciences (PI: Benjamin Rybicki, PhD, Mentor). The study includes men diagnosed and treated for prostate cancer (1999-2004) at Henry Ford Health System in Detroit, Michigan. The parent study now includes nearly 900 men, 42% of whom are African-American. Comprehensive information on dietary intake, physical activity, occupational exposures and medical history, including PSA and DRE screening, are available for these subjects and will be included in the analysis which will assess the independent contribution of housing status to prostate cancer risk. Area-level housing data were captured from the U.S. Census 2000.

Significance

Very few risk factors are known for prostate cancer, although the disease accounts for nearly 40% of all cancers diagnosed in African American men. This study is examining housing, a previously unexplored area in prostate cancer research. Although this initial study is being conducted in only one CRN site, the CRN provides a unique environment for area-level studies to be conducted, as individual level data, often missing from area-based studies is available and sites are gaining experience in using Geographic Information Systems (GIS) in combination with U.S. Census data. In the future, findings from this study will be used to conduct a larger prostate cancer study across multiple CRN sites, as residential segregation and housing patterns differ nationally.

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Health Care Improvement for Aging Women Direct link to this project

Project Staff:
  • Investigator: Andrea LaCroix, Group Health

Funding Source: National Institutes of Health
Funding Start Date: 1/1/2007

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Effect of HIPAA Privacy Rule on Health Research Direct link to this project

Project Staff:
  • Project Leader: Sarah Greene, Group Health
  • Investigator: Ed Wagner, Group Health

Funding Source: Institute of Medicine
Funding Start Date: 11/1/2006

Description: minus sign Hide

Background

Anecdotes and small studies have suggested that the HIPAA Privacy Rule and its procedural requirements have hampered research without meaningfully protecting the privacy of health information. The Institute of Medicine (IOM) commissioned a series of studies to examine the impact of the HIPAA Privacy Rule on health research. The Cancer Research Network, which is a multi-site collaboration involving members of the HMO Research Network (HMORN) was identified as one of the study settings in which to examine the effects of HIPAA.

Study Aim

The aim of this project was to assess researchers’ and IRB administrators’ perspectives on the HIPAA Privacy Rule as it pertains to their research and their involvement in multi-site studies, including direct impact on one or more of the researchers’ own studies, steps taken to mitigate the impact of the HIPAA Privacy Rule provisions, and extent to which the IRB administrators and researchers held converging viewpoints on the impact of the HIPAA Privacy Rule.

Methods

Three different data collection strategies were employed:

  1. Web-based survey of investigators in the Cancer Research Network
  2. Follow-up telephone survey for investigators who report having a study affected by the HIPAA Privacy Rule Regulations
  3. Mailed survey of IRB Administrators at the 15 HMORN sites

Significance

To our knowledge, this is the first study that has concurrently examined the views of IRBs and researchers at the same site. In addition, this study afforded an opportunity to both assess the interpretation of the HIPAA Privacy Rule at different institutions who collaborate frequently, and examine the impact of this Rule on multi-site studies.

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Diffusion of Ovarian Cancer Treatment Direct link to this project

Project Staff:
  • Project Leader: Larissa Nekhlyudov, Harvard Pilgrim Health Care
  • Investigator: Andrea Altschuler, KP Northern California
  • Investigator: Andrew Williams, KP Hawaii
  • Investigator: Christine Neslund-Dudas, Henry Ford Health System
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Ed Wagner, Group Health
  • Investigator: Erin Aiello Bowles, Group Health
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Virginia Quinn, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 9/1/2006

Area(s) of Research: Dissemination & Diffusion

Tumor Site(s): Ovary

Phase(s) of Care: Treatment

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The overall goal of this project is to examine the use of combined intravenous and intra-peritoneal chemotherapy for advanced ovarian cancer in Cancer Research Network (CRN) sites. The study will rely on the use of automated data from the Virtual Data Warehouse (VDW) to track treatment patterns, and will collaborate and coordinate with a parallel National Comprehensive Cancer Network (NCCN) study.

The CRN sites involved in this study will: 1) use automated VDW data to identify ovarian cancer cases; 2) collect information on tumor characteristics, stage, and treatment patterns as available; 3) validate these data against a random sample of chart reviews in order to determine the accuracy of our automated data to define stage and treatment patterns before and after the clinical announcement.

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Is Stroke a Late Effect of Chemotherapy? Direct link to this project

Project Staff:
  • Project Leader: Ann Geiger, Wake Forest University
  • Investigator: Diana Buist, Group Health
  • Investigator: Fabian Camacho, Wake Forest University
  • Investigator: Leslie Bernstein, City of Hope Cancer Center
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 7/1/2006

Area(s) of Research: Epidemiology & Surveillance; Outcomes; Survivorship Research

Tumor Site(s): Breast; Colorectal; Lymphoma; Ovary; Other

Phase(s) of Care: Survivorship

Description: minus sign Hide

This grant, led by Dr. Ann Geiger (Wake Forest University; formerly of KPSC), explores the hypothesis that chemotherapy may increase stroke risk for years afterward. The study team will estimate the relative risks of stroke as a result of chemotherapy among ethnically diverse patients with bladder, female breast, colorectal, Hodgkin’s lymphoma, adult leukemia, multiple myeloma, non-Hodgkin’s lymphoma, and ovarian cancers, adjusting for numerous demographic and clinical characteristics.

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Multiplex Genetic Susceptibility Testing: An Interdisciplinary Collaboration Direct link to this project

Project Staff:
  • Project Leader: Eric Larson, Group Health
  • Investigator: Collen McBride, National Human Genome Research Institute
  • Investigator: Larry Brody, National Human Genome Research Institute
  • Investigator: Robert Reid, Group Health
  • Investigator: Sharon Hensley Alford, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 3/1/2006

Area(s) of Research: Health Literacy; Behavior

Phase(s) of Care: Prevention; Screening

Description: minus sign Hide

The Multiplex Initiative, led by Dr. Colleen McBride (NHGRI), is a collaborative effort between NHGRI, NCI, and GHC that was funded through a CRN supplement from NHGRI. The objectives are to explore individual response to being offered the Multiplex Genetic Test for complex common diseases and receiving test results, and to develop an infrastructure through which future research participants can be offered the Multiplex Genetic Test protocol.

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Quality of Patient-Centered Cancer Care, Communication and Coordination Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Erin Aiello Bowles, Group Health
  • Investigator: Sarah Greene, Group Health
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 10/10/2005

Area(s) of Research: Health Services; Quality of Care

Phase(s) of Care: Treatment

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There is growing concern about the human and technical quality of care received by Americans with cancer. To this end, this contract sought to describe the care received by typical cancer patients in several US communities. The overall goal of the project was to provide a comprehensive assessment of the quality of American cancer care, especially quality as perceived and experienced by patients and their families in undergoing care, to illuminate the factors that facilitate or impede high quality cancer care in communities. We synthesized information from the literature; interviews with health policy experts, healthcare leaders, and researchers; and site visits to three communities where we have conducted focus groups involving practicing clinicians, other care providers, and patients and families. The three site visits, which including two CRN communities, Detroit, MI and the Worcester, MA area of Central Massachusetts, involved visits to multiple organizations that provide services to cancer patients. The information collected has contributed to the development of a conceptual framework that defines the characteristics of effective systems of cancer care.

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Comparing pancreatic cancer identification using health plan automated data & SEER cancer registry Direct link to this project

Project Staff:
  • Project Leader: Reina Haque, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2005

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Pancreas

Phase(s) of Care: Diagnosis

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The aim of this study was to inform the development of an automated data algorithm using the Virtual Data Warehouse (VDW) and validation with chart abstraction to rapidly identify patients with recently diagnosed pancreatic cancer. The challenge encountered in this study was extracting imaging data from radiology databases. Unlike cancers of other anatomic sites, the diagnosis of pancreatic cancer is also based on imaging procedures in addition to pathology information. This pilot study generated preliminary data for a larger study proposal.

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Development of a method to assess obesity and treatment via EMR (IT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Brian Hazlehurst, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2005

Area(s) of Research: Epidemiology & Surveillance; Methods

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This study had three aims: 1) Develop the concepts and rules necessary to assess obesity status, prevention, and treatment using EMRs; 2) Use this knowledge to extend MediClass, a technology for analyzing both coded- and free-text clinical data in any EMR, to the obesity domain; and, 3) Use this MediClass obesity application to describe obesity treatment in primary care within KPNW. The project team built an automated method to classify the EMR for assessing health status and care delivery for obese and overweight patients. This automated method provides an important first step in allowing comprehensive assessment of obesity status, counseling and treatment in large populations. A follow-on R01 application to advance this work at HealthPartners and Harvard Pilgrim Health Care was submitted in March, 2008 (Victor Stevens, PI).

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Development of a shareable analytic dataset for studies of racial disparities (IT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Chyke Doubeni, Meyers Primary Care Institute
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2005

Area(s) of Research: Health Disparities

Phase(s) of Care: Diagnosis

Description: minus sign Hide

The aim of this project was to develop a shareable analytic de-identified dataset to examine racial disparities in survival and cancer stage at diagnosis. We added data programs to the VDW to collect comorbidity data, which resulted in the establishment of an annotated centrally available SAS program designed to extract data for establishing the Charlson Comorbidity Index for newly diagnosed cancer patients. Also, we linked the cause of death codes to look-up tables to identify deaths due to specific cancers. With a project led by Dr. Chyke Doubeni, the project team is still attempting to include socioeconomic variables from the local sites through geocoded links to census data.

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Diffusion of breast MRI technology in community clinical settings (IT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Larissa Nekhlyudov, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2005

Area(s) of Research: Dissemination & Diffusion

Tumor Site(s): Breast

Phase(s) of Care: Screening; Diagnosis

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Magnetic Resonance Imaging (MRI) of the breast has been approved by the FDA for diagnostic purposes but not for screening of the general population, yet uses of both have been reported in medical practices and appear to be rising. The aim of this study was to better understand the utilization of breast MRI and the variations in use across community clinical settings. Preliminary findings suggest that the use of breast MRI by 225 women at HPHC between 2001-04 with prior breast cancer increased from 2001 to 2002, but then remained stable through 2004. The indications were evenly distributed and the utilization of breast MRI steadily increased among women without prior breast cancer, mostly for diagnostic purposes and less commonly for screening. Additional analyses assessing the downstream effects of breast MRI and a larger study to examine the diffusion of breast MRI across the CRN are pending.

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Increasing Technology to Maximize Use of the VDW at all CRN Sites (IT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Margaret Gunter, Lovelace Clinic Foundation
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Robert T. Greenlee, Marshfield Clinic Research Foundation
  • Investigator: Thomas Vogt, KP Hawaii

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2005

Area(s) of Research: Methods

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This supplement allowed migration of the local VDW data to a dedicated server at eight CRN sites. This enhanced our ability to generate rapid, high-quality turn-around on projects. The utility of the VDW has become evident to more people and it is being more widely used. The VDW is now considered to be a resource beyond the CRN and is viewed as a utility that serves multiple consortia and many single-site projects. This supplement funded two of the newer CRN sites: Lovelace and Marshfield, which helped them start developing their local VDW.

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Outcomes of genetic counseling for heritable breast/ovarian cancer: Feasibility of identifying cohort through EMR (IT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Brian Hazlehurst, KP Northwest
  • Project Leader: Emily Harris, KP Northwest

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2005

Area(s) of Research: Epidemiology & Surveillance; Methods

Tumor Site(s): Breast; Ovary

Phase(s) of Care: Other

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While genetic counseling and testing for inherited breast/ovarian cancer susceptibility are widely available, little is known about how they impact health or health care behaviors. This study created a method to identify those who are eligible for counseling, those who receive counseling, and the reasons for that counseling, using automated analysis of the EMR. We developed and evaluated a MediClass application, allowing for comprehensive search of the EMR, including both coded and free-text data fields. The study demonstrated that individuals who are at risk and who receive genetic counseling for inherited breast/ovarian cancer susceptibility can be automatically identified. This study provides the basis for developing search and categorization algorithms for future large, collaborative studies.

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System Failures Contributing to Chemotherapy Error - A Project of the HMORN Center of Education in Research and Therapeutics (CERT) Direct link to this project

Project Staff:
  • Project Leader: Jerry Gurwitz, Meyers Primary Care Institute
  • Investigator: Ann Von Worley, Lovelace Clinic Foundation
  • Investigator: Doug Roblin, KP Georgia
  • Investigator: Kathleen Walsh, Meyers Primary Care Institute
  • Investigator: Lisa Herrinton, KP Northern California

Funding Source: Agency for Healthcare Research and Quality
Funding Start Date: 9/30/2005

Area(s) of Research: Methods

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Purpose

Outpatients with cancer receive complicated medication regimens in the clinic and home. Medication errors in this setting are not well described. We aimed to determine rates and types of medication errors and systems factors associated with error in outpatients with cancer.

Methods

We retrospectively reviewed records from visits to three adult and one pediatric oncology clinic in the Southeast, Southwest, Northeast, and Northwest for medication errors using established methods. Two physicians independently judged whether an error occurred (k=0.65), identified its severity (k=0.76), and listed possible interventions.

Results: Of 1,262 adult patient visits involving 10,995 medications, 7.1% (n=90; 95% CI, 5.7% to 8.6%) were associated with a medication error. Of 117 pediatric visits involving 913 medications, 18.8% (n=22; 95% CI, 12.5% to 26.9%) were associated with a medication error. Among all visits, 64 of the 112 errors had the potential to cause harm, and 15 errors resulted in injury. There was a range in the rates of chemotherapy errors (0.3 to 5.8 per 100 visits) and home medication errors (0 to 14.5 per 100 visits in children) at different sites. Errors most commonly occurred in administration (56%). Administration errors were often due to confusion over two sets of orders,one written at diagnosis and another adjusted dose on the day of administration. Physician reviewers selected improved communication most often to prevent error.

Conclusion

Medication error rates are high among adult and pediatric outpatients with cancer. Our findings suggest some practical targets for intervention, including improved communication about medication administration in the clinic and home.

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New Markers: Clinical & Pathologic Predictors of DCIS Direct link to this project

Project Staff:
  • Project Leader: Laurie Habel, KP Northern California
  • Investigator: Larissa Nekhlyudov, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 9/1/2005

Area(s) of Research: Biology & Etiology; Epidemiology & Surveillance; Genetics

Tumor Site(s): Breast

Phase(s) of Care: Survivorship

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The specific aim of the CRN2 DCIS Administrative Supplement is to conduct immunohistochemistry and gene expression assays on the remaining subset of DCIS patients with a recurrence (cases) and a matched sample of those who remain disease free (controls) for which these studies were not covered by Core funds under “Clinical and Pathologic Predictors for Recurrence after DCIS”

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HRT Initiation & Cessation after WHI Results Direct link to this project

Project Staff:
  • Project Leader: Diana Buist, Group Health
  • Investigator: Diana Miglioretti, Group Health
  • Investigator: Feifei Wei, HealthPartners Research Foundation
  • Investigator: Katherine Newton, Group Health
  • Investigator: Onchee Yu, Group Health
  • Investigator: Susan Andrade, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 3/1/2005

Area(s) of Research: Dissemination & Diffusion; Epidemiology & Surveillance; Health Services; Policy; Behavior

Description: minus sign Hide

On May 31, 2002, the Women’s Health Initiative (WHI) randomized trial of hormone therapy (HT) was stopped early because the risks of HT were found to outweigh the benefits. Women randomized to estrogen plus progestin therapy (EPT) experienced an excess risk of invasive breast cancer, coronary heart disease, stroke, venous thromboembolism, and pulmonary embolism compared to women randomized to placebo. To ascertain the effect of this pivotal announcement in community-based delivery settings, the CRN received an NCI administrative supplement to conduct an observational cohort study using automated pharmacy dispensing data. This study, led by Dr. Diana Buist (GHC), provided important information on the rapid translation of the WHI results into clinical practice, use of HT in relation to current clinical recommendations, and patterns of re-initiation after cessation. These findings demonstrate the CRN’s ability to rapidly examine changes in therapies over time. A follow-up study being conducted by NCI investigators in collaboration with two CRN sites is examining these data at the individual patient level to determine the association between patterns of HT usage and subsequent breast cancer occurrence. The results of this study will be utilized to improve the specification of breast cancer natural history used in the prevention component of breast cancer simulation models (Cancer Intervention and Simulation Modeling Network [CISNET]).

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Anti-estrogen Therapies for Breast Cancer Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Ann Geiger, Wake Forest University
  • Investigator: Diana Buist, Group Health
  • Investigator: Erin Aiello Bowles, Group Health
  • Investigator: Lisa Herrinton, KP Northern California
  • Investigator: Lois Lamerato, Henry Ford Health System
  • Investigator: Reina Haque, KP Southern California
  • Investigator: Sarah Greene, Group Health
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2005

Area(s) of Research: Dissemination & Diffusion; Epidemiology & Surveillance

Tumor Site(s): Breast

Phase(s) of Care: Survivorship

Description: minus sign Hide

As early as 2001, several randomized trials demonstrated that adjuvant aromatase inhibitor treatment is superior to tamoxifen for decreasing breast cancer recurrence among women with estrogen receptor positive breast cancer. CRN investigators used automated pharmacy data from seven CRN sites to assess the use of aromatase inhibitors and tamoxifen between 1996 and 2003. This study, co-led by Dr. Edward Wagner (GHC) and Ms. Erin Aiello Bowles (GHC), also included an oncologist survey to assess whether and how CRN organizations and oncology groups made policy decisions about cancer interventions. Aromatase inhibitor use rose dramatically after 2001, while tamoxifen use decreased. Regardless of whether their site had formal treatment guidelines, almost all oncologists reported prescribing aromatase inhibitors under various circumstances: metastatic breast cancer, after completion of tamoxifen, or in lieu of tamoxifen.

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Medications and Colorectal Cancer Risk Direct link to this project

Project Staff:
  • Project Leader: Denise Boudreau, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2004

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Colorectal

Description: minus sign Hide

Specific Aims

  1. To investigate the relationship between colorectal cancer risk and the use of acid suppressive medications including proton pump inhibitors and histamine receptor antagonists.
  2. To investigate the relationship between colorectal cancer risk among men and women age 40 years and older and the use of cholesterol lowering agents including HMG-CoA reductase inhibitors (statins), bile-acid sequestrants, fibric acid derivatives, and niacin.
  3. To investigate the relationship between colorectal cancer risk and the use of antihypertensive agents including calcium channel blockers (CCBs), beta-adrenergic blockers, angiotensin converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor antagonists, and diuretics.

As secondary aims, we proposed to explore the association between colorectal cancer risk and a history of several medical conditions and medications, including: peptic ulcer disease and/or Helicobacter pylori infection; and diabetes mellitus and antidiabetic medications. We also proposed to conduct preliminary analyses examining the association between the use of Cox-2 inhibitors and colorectal cancer risk.

Methods

We conducted a case-control study among men and women age 40 years and older enrolled in Group Health Cooperative (Group Health) using automated health plan data to ascertain information on medication use and automated pharmacy data to identify medications of interest (statins, antihypertensives, acid suppressants, and diabetic medications), and potential confounders for cases and controls during the 10 years prior to reference date. Incident colorectal cancer cases diagnosed during January 1, 2000 to December 31, 2003 were identified from the western Washington Surveillance, Epidemiology, and End Results (SEER) cancer registry. A total of 665 cases were included in the study. One control was selected per case and matched on age (month/year), gender, enrollment (month/year start date), and reference date. Controls met the same exclusion requirement of cases and were required to be residing in one of 13 western Washington counties covered by the SEER registry. Group Health’s Institutional Review Board approved the study.

Results

Risk for colorectal cancer was not associated with use of statins (odds ratio, 1.02; 95% CI, 0.65-1.59), other lipid-lowering agents (odds ratio, 1.31; 95% CI, 0.70-2.47), angiotensin-converting enzyme inhibitors (odds ratio, 0.98; 95% CI, 0.67-1.43), calcium channel blockers (odds ratio, 1.06; 95% CI, 0.72-1.55), or diuretics (odds ratio, 1.00; 95% CI, 0.70-1.44). Risk did not differ by duration of medication use, including long-term use.

Conclusions

Risk for colorectal cancer was not reduced by use of statins or angiotensin-converting enzyme inhibitors. Other lipid-lowering and antihypertensive medications were also not associated with colorectal cancer risk.

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Multicenter Study of Pancreatic Cancer Etiology Direct link to this project

Project Staff:
  • Project Leader: Meg Mandelson, Group Health
  • Investigator: Stephen K. Van Den Eeden, KP Northern California

Funding Source: National Cancer Institute
Funding Start Date: 7/15/2004

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Pancreas

Phase(s) of Care: Diagnosis

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The Pancreatic Cancer Investigation: Finding Causes (PACIFIC) study is a large, comprehensive case-control study with recruitment from two HMOs that have infrastructure to support ultra-rapid case identification during diagnostic evaluation. Led by Dr. Margaret Mandelson (GHC), Dr. John Potter (Fred Hutchinson Cancer Research Center), and Dr. Stephen Van Den Eeden (KPNC), this study’s methods allow enrollment of patients who represent the full spectrum of disease, including those typically omitted from prior epidemiologic research because of death shortly following diagnosis.

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Statins & Risk of Site-specific Cancers Direct link to this project

Project Staff:
  • Project Leader: Denise Boudreau, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 4/27/2004

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Breast; Prostate; Other

Description: minus sign Hide

Specific Aims

Our primary aims were:

  1. To evaluate the association between statin use and breast cancer risk among women age 45 years and older.
  2. To evaluate the association between statin use and prostate cancer risk among men age 45 years and older.

Our secondary aims were:

  1. To assess the effect that cumulative duration of exposure to statins has on the risk of breast and prostate cancers.
  2. To assess if the risk of breast and prostate cancer differ by type of statin.
  3. To evaluate the association between statin use and stage at diagnosis for breast and prostate cancers. (We were unable to this aim because the majority of breast and prostate cancers were stage I or stage II. Instead, we evaluated aggressive prostate cancer risk by statin use and the association between statin use and breast density.)
  4. To evaluate the association between statin use and histology of breast cancer
  5. To evaluate the association between statin use and female reproductive/genital organ cancers (uterine, ovarian, and vaginal) among women age 45 years and older.

Methods

We conducted a retrospective cohort study from 1990 through 2003 within Group Health Cooperative (GHC). Cancer cases were identified through the western Washington Surveillance, Epidemiology, and End Results registry. Information on statin use and covariates was obtained from automated administrative data files, which include pharmacy records, laboratory values, hospitalizations, outpatient visits, and cause of death. Automated data from GHC’s Breast Cancer Surveillance Program will be used to identify other covariates for the women under study such as reproductive history, menopausal status, family history of cancer, body mass index, and frequency of mammography screening for the female cohort.

Results

The prevalence of statin use continues to rise among older adults and the rates of incident breast and prostate cancers are increasing among this same population. Exploring the association between statin use and these two cancers is an important part of the effort to understand the etiology of cancer, address drug safety questions, and a possible opportunity for prevention. Results of this grant have contributed to the literature in this area and our useful in disentangling the complicated relation between statins and cancer, as well as reassuring the public on the safety of statins as they relate to cancer.

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Patterns of Preventive Services Utilization of Cancer Survivors (Research Supplement for Underrepresented Minorities Program) Direct link to this project

Project Staff:
  • Project Leader: Chyke Doubeni, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 4/1/2004

Area(s) of Research: Epidemiology & Surveillance; Health Disparities

Phase(s) of Care: Prevention

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Background

Despite improvements in overall case-fatality rates over the past two decades, disparities in survival from cancer particularly between Blacks and Whites have continued to increase. The causes of these disparities remain unclear. Given that many forms of cancer are preventable through screening, and potentially curable, it is imperative to identify the underlying causes of racial and ethnic differences in survival. The goal of this proposal is to identify potentially modifiable contributing factors to disparities in survival from cancer that may be amenable to system-based interventions.

Study Aims

  1. Determine the utilization patterns of cancer early detection services among women following diagnosis of incident breast cancer or cervical neoplasm
  2. Identify socio-demographic characteristics (e.g. age and race), clinical characteristics (e.g. comorbid conditions, tumor type and stage), and healthcare utilization patterns (e.g. number of visits to primary care provider) that may predict use of cancer early detection services following diagnosis of incident breast or cervical cancer.

Methods

Dr. Doubeni was funded through a research supplement for underrepresented minorities from the National Cancer Institute to the Cancer Research Network. The goal of that funding was to enhance Dr. Doubeni’s ability to perform independent research “that develops and tests rational scientific hypotheses based on fundamental and clinical research findings with the potential for improving the medical care of cancer patients”. The Continuing Umbrella of Research Experiences (CURE) program for underrepresented minority populations aimed to “broaden participation of underrepresented minority individuals in cancer-related research and training activities while encouraging them to become independent/competitive cancer researchers”.

Significance

Dr. Doubeni’s research experiences over the past 2 years have focused on: (1) use of large longitudinal databases; (2) racial and ethnic disparities in cancer stage and survival; (3) studies of screening/surveillance testing for disease among cancer patients and among patients with cardiovascular risk factors; (4) studies of treatment patterns including trends in treatment over time; and (5) characterizing comorbid medical conditions. Dr. Doubeni is therefore poised to becoming a successful independent investigator. His future research training will build on this foundation.

The goals of the Minority Supplement Program were achieved in that Dr. Doubeni successfully received a mentored career development award at the end of the supplement funding. Dr. Doubeni now has a strong foundation on which he will build a successful career as a nationally recognized independently-funded clinician-investigator.

Project Status

This project was funded under the auspices of the CRN by the National Cancer Institute for Dr. Doubeni’s research training activities. Dr. Doubeni embarked on a program of aggressive research career development. He completed several important research projects that have resulted in several peer-reviewed publications including a widely publicized report on the care of cancer survivors. The public health importance of Dr. Doubeni’s research activities has been underscored by the general public’s interest in Dr. Doubeni’s published work.

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African American Disparities in Lung Cancer Direct link to this project

Project Staff:
  • Project Leader: Martin Tammemagi, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 3/1/2004

Area(s) of Research: Epidemiology & Surveillance; Health Disparities

Tumor Site(s): Lung

Phase(s) of Care: Treatment; Survivorship

Description: minus sign Hide

Lung is the leading cause of cancer death for both men and women. The incidence and mortality rates of lung cancer are 50% and 40% higher in Black men compared to White men, respectively, and further race/ethnic disparities exist in receipt of treatment and survival. At HFHS, compared to White women, Black male lung cancer patients have the worst survival (hazard ratio (HR) = 1.41), followed by Black women (HR = 1.37) and White men (HR = 1.29). Our recent retrospective study indicates that differences in SES, marital status, smoking, illicit drug use, stage, histopathology, comorbidity and symptoms explained disparities in non-receipt of optimal treatment and survival in localized and advanced disease. The Charlson Index failed to capture important data.

In addition, recent studies have demonstrated that certain polymorphisms in DNA repair genes (e.g., OGG1 gene) are associated with increased risk of lung cancer. Differences in distributions of such polymorphisms by race/ethnicity have not been well studied.

The pilot study proposes a.) to expand on our current work on comorbidity as a factor in treatment and survival disparities and b) to begin to evaluate the role of polymorphisms in DNA repair genes in race/ethnic disparities in lung cancer risk.

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Do Acute and Chronic Illness Trump Preventive Care? A Case Study of Breast and Colon Cancer Screening Direct link to this project

Project Staff:
  • Project Leader: Josh Fenton, University of California Davis Medical Center
  • Investigator: Michael Von Korff, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 3/1/2004

Area(s) of Research: Health Services

Tumor Site(s): Breast; Colorectal

Phase(s) of Care: Prevention; Screening

Description: minus sign Hide

Our initial funding was to characterize health service use patterns using a novel taxonomy of visits based on the Oregon Prioritized List of Services and to identify whether visit pattern was associated with cancer screening. Our characterization essentially yielded null results, and we identified a number of limitations to the taxonomy. We therefore tested other hypotheses with the dataset, including the associations between cancer screening and i) receipt of preventive health examinations and ii) continuity of primary care. The published paper describes the contribution of primary care use to colorectal cancer screening across the entire health plan population. We plan no further analyses with the dataset.

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Investigation of Age-specific Differences & Cancer of the Cecal Colon Direct link to this project

Project Staff:
  • Project Leader: Steven Dudas, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 3/1/2004

Area(s) of Research: Biology & Etiology

Tumor Site(s): Colorectal

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Background

Cancer of the colon, which has a median age of occurrence of 72 years, is the third most commonly diagnosed cancer in the United States that afflicts men and women. Understanding the effects of normal or usual age-related changes on biological-functions that contribute to carcinogenesis in the elderly is an important area of research. The objective of this pilot study is to begin to evaluate the aspects of free radical damage and induction of apoptosis in colon cancer with respect to age at diagnosis.

Specific Aim

In a cohort of colon cancer patient diagnosed with adenocarcinoma of the cecal-colon, we proposed to determine with respect to age: levels of oxidative DNA damage, apoptotic activity and the expression levels of pro-apoptotic and anti-apoptotic genes.

Methods

This study was designed to evaluate these issues in archival human colon tumor tissue samples using standard immumohistochemistry techniques.

Significance

The ultimate objective of characterizing the tumor biology of the elderly is to identify useful markers that can predict disease outcome and perhaps response to treatment and intervention. Understanding the functional mechanisms underlying the age-related increase incidence of the disease in elderly can identify strategies for prevention or delaying the onset of disease.

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Accuracy of Automated Data on Colorectal Cancer Screening Direct link to this project

Project Staff:
  • Project Leader: Reina Haque, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2004

Area(s) of Research: Epidemiology & Surveillance

Tumor Site(s): Colorectal

Phase(s) of Care: Screening

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Background

The Healthy People 2010 report designated increasing colorectal cancer screening a public health priority. Colorectal cancer screening exams include fecal occult blood test, sigmoidoscopy, colonoscopy, and barium enema. Increasing screening rates and determining which exam to use in a given situation requires accurate data. Automated data provide opportunities to examine screening in large populations, but questions about accuracy and validity have not been addressed adequately. For example, health maintenance organizations use automated data to calculate quality measures despite the lack of indication information for the exams.

Study Aims

  1. Develop an algorithm to differentiate between screening and diagnostic endoscopy (sigmoidoscopy and colonoscopy) procedures using automated databases.
  2. Validate the algorithm to distinguish the indication of the endoscopy tests with outpatient and inpatient medical records.

Methods

We developed a preliminary automated data algorithm to distinguish between screening and diagnostic colorectal cancer endoscopy tests and then assessed the algorithm’s ability to correctly classify the exams using paper medical records as the gold standard. The algorithm used diagnostic codes to identify the indication of the endoscopies.

Results

The algorithm’s ability to correctly classify the indication varied by endoscopy type. For sigmoidoscopy, the algorithm and medical record agreed for 62% of exams classified as diagnostic and 81% of exams classified as screening. For colonoscopy, agreement increased to 75% for the diagnostic classification, but agreement decreased to 64% for the screening classification.

Significance

Our findings suggest studies relying solely on automated data may overestimate screening rates if indication is not considered. Automated algorithms may be efficient tools to determine the indication of endoscopies; however, with future improvements, the preliminary algorithm may better differentiate screening from diagnostic exams.

Project Status: This pilot study was supported through the CRN2. The project leader is Reina Haque, PhD. Findings from the main paper on the automated data algorithm are available in the 2005 issue of the Journal of the National Cancer Institute Monograph. A complimentary study using this algorithm was published in July 2007 issue of Cancer. This paper describes correlates of screening endoscopy among members of the California Men’s Health Cohort, a cohort nearly 80,000 men who are members of two of the largest health plans based in California, Kaiser Permanente Southern & Northern California.

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Michigan Center for Health Communications Research Direct link to this project

Project Staff:
  • Project Leader: Vic Strecher, University of Michigan
  • Investigator: Dennis Tolsma, KP Georgia
  • Investigator: Gwen Alexander, Henry Ford Health System
  • Investigator: Jennifer McClure, Group Health
  • Investigator: Sarah Greene, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 9/26/2003

Area(s) of Research: Communication; Outcomes; Behavior

Description: minus sign Hide

The MCHCR (Dr. Vic Strecher, PI) is one of four NCI-designated Centers of Excellence in Cancer Communications Research. It was funded through a P50 grant and entails collaborating with the CRN to develop and test an efficient, theory-driven model for generating tailored health behavior interventions. The Center supports three core research projects along with several developmental studies. Core Project 1 (Project Quit) is testing a tailored, Web-based smoking cessation intervention; Core Project 2 (Eat for Life) is developing a tailored, print-based intervention designed to promote fruit and vegetable intake among African American adults; and Core Project 3 (Guide to Decide) is using a decision aid about breast cancer chemoprevention to test different approaches to presenting health risk information. All projects will employ a resolution IV fractional factorial design to determine the potential active ingredients of tailoring, including, but not limited to, communication factors such as message content, message framing, message source, and graphical presentation; individual factors such as culture and socio-demographics; and psychometric factors such as motivation and self-efficacy. The MCHCR collaborates with three CRN members (GHC, HFHS, and KPGA) to recruit and enroll research subjects.

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Using Electronic Medical Records (EMRs) to Improve Adherence to Tobacco Control Guidelines Direct link to this project

Project Staff:
  • Project Leader: Victor Stevens, KP Northwest
  • Investigator: Brian Hazlehurst, KP Northwest
  • Investigator: Dean Sittig, KP Northwest
  • Investigator: Jack Hollis, KP Northwest
  • Investigator: Jonathan Winickoff, Harvard Pilgrim Health Care
  • Investigator: Leif Solberg, HealthPartners Research Foundation
  • Investigator: Nancy Rigotti, Harvard Pilgrim Health Care
  • Investigator: Thomas Vogt, KP Hawaii
  • Investigator: Virginia Quinn, KP Southern California
  • Investigator: Erik France, KP Colorado

Funding Source: National Cancer Institute
Funding Start Date: 3/11/2003

Area(s) of Research: Health Services; Informatics; Quality of Care; Behavior

Description: minus sign Hide

EMRs offer an attractive method for evaluating guideline implementation and improving quality of care. This study, led by Dr. Victor Stevens (KPNW), developed a method for coding tobacco-cessation activities (the “Five A’s”) in four HMOs using EMRs. Data were obtained from coded fields, and information entered in free-text fields (e.g., progress notes) was coded using MediClass, a natural language processing program. The team evaluated the accuracy of MediClass in assessing whether clinicians adhered to the national tobacco treatment guidelines (the “Five A’s”) with patients. MediClass performed as well as the human abstractors and was found to be practical for assessing primary care adherence to the tobacco treatment guidelines.

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Clinical & Pathologic Predictors of Ductal Carcinoma in Situ Direct link to this project

Project Staff:
  • Project Leader: Laurie Habel, KP Northern California
  • Investigator: Charles Quesenberry, KP Northern California
  • Investigator: Craig Earle, Beth Israel Deaconess Medical Center
  • Investigator: Larissa Nekhlyudov, Harvard Pilgrim Health Care
  • Investigator: Reina Haque, KP Southern California
  • Investigator: Stuart Schnitt, Beth Israel Deaconess Medical Center
  • Investigator: Suzanne Fletcher, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 3/1/2003

Area(s) of Research: Biology & Etiology; Epidemiology & Surveillance

Tumor Site(s): Breast

Phase(s) of Care: Survivorship

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In this project, led by Dr. Laurel Habel (KPNC), investigators at three CRN sites are studying clinical and pathologic factors that could be used to identify DCIS patients at high and low recurrence risk. From medical records, investigators have identified DCIS patients treated with breast-conserving surgery (BCS) and followed for recurrence. Recurrence rates after BCS for DCIS have declined as treatment with adjuvant radiotherapy and tamoxifen have increased; adjuvant treatment use does not appear to differ markedly across racial/ethnic groups; and surveillance mammography after BCS for DCIS declines over time and becomes inadequate. This large, comprehensive study on prognostic factors will improve understanding of the natural history of DCIS and help in developing individually tailored DCIS treatment strategies. It also serves as a model of a CRN project that benefits from the unique electronic and biologic specimens available in the CRN health plans.

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Breast Cancer Treatment Effectiveness in Older Women Direct link to this project

Project Staff:
  • Project Leader: Rebecca Silliman, Boston University Medical Center
  • Investigator: Ann Geiger, Wake Forest University
  • Investigator: Diana Buist, Group Health
  • Investigator: Feifei Wei, HealthPartners Research Foundation
  • Investigator: Floyd Frost, Lovelace Clinic Foundation
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Soe Soe Thwin, Boston University Medical Center
  • Investigator: Terry Field, Meyers Primary Care Institute
  • Investigator: Timothy L. Lash, Boston University Medical Center
  • Investigator: Virginia Quinn, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 2/1/2003

Area(s) of Research: Epidemiology & Surveillance; Health Disparities; Health Services; Outcomes; Quality of Care

Tumor Site(s): Breast

Description: minus sign Hide

Dr. Rebecca Silliman (Boston University), a member of the CRN Academic Liaison Committee, led this large-scale cohort study of the care and outcomes of 1,859 older women with breast cancer at six CRN sites. By reviewing medical records and using administrative data, information was collected on initial surgery, adjuvant treatments, long-term surveillance, and recurrence and mortality outcomes. The team compared the effectiveness of different treatment and surveillance patterns, and identified the characteristics of providers, tumors, and patients associated with various treatment choices. The study found that less-than-standard treatment is associated with increased rates of recurrence and breast cancer-specific mortality, while mammography surveillance during the first five years after diagnosis is associated with a reduced rate of breast cancer mortality.

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Making Effective Nutritional Choices Direct link to this project

Project Staff:
  • Project Leader: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Dennis Tolsma, KP Georgia
  • Investigator: George W. Divine, Henry Ford Health System
  • Investigator: Gwen Alexander, Henry Ford Health System
  • Investigator: Jennifer McClure, Group Health
  • Investigator: Vic Strecher, University of Michigan

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2003

Area(s) of Research: Communication; Behavior

Description: minus sign Hide

Dr. Christine Cole Johnson (HFHS) led the development and evaluation of an individually tailored, Web-based program to promote daily fruit and vegetable (F&V) consumption. Its efficacy was tested in a randomized trial of five HMOs. The online intervention was shown to be effective in the diverse sample of healthy adults who enrolled. All three intervention arms (untailored and tailored Web program and tailored Web program plus email support) showed early and sustained increases of more than two F&V servings per day. The untailored Web program arm was least effective. Those participating online at a higher rate had more gain in F&V servings, the retention rate was high, and reported satisfaction with the online program overall was high. Analyses exploring the effects of additional variables on dietary behaviors are ongoing.

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Optimizing breast cancer outcomes: BMI, tumor markers and quality of care (IT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Diana Buist, Group Health
  • Investigator: Emily White, Fred Hutchinson Cancer Research Center
  • Investigator: Peggy Porter, Fred Hutchinson Cancer Research Center
  • Investigator: Rebecca Silliman, Boston University Medical Center
  • Investigator: Steve Taplin, National Cancer Institute

Funding Source: American Cancer Society
Funding Start Date: 1/1/2003

Tumor Site(s): Breast

Description: minus sign Hide

This Clinical Research Training Grant application is multidisciplinary in design. Collaborators with expertise in breast cancer epidemiology, prognostic factors, breast pathology and quality of breast cancer care will provide mentorship and support to assist Dr. Buist to develop as an independent academic researcher. In a defined population-based managed care setting, Dr. Buist plans to pursue a three-year mentored program that consists of two research projects, teaching epidemiology, and formal and informal training in cancer pathology, pharmacology, and analysis. This application is jointly sponsored by faculty from the Center for Health Studies at Group Health Cooperative, the Fred Hutchinson Cancer Research Center, and the University of Washington.

Advances in breast cancer screening and detection have increased the proportion of long-term breast cancer survivors. Thus, more women are at risk for breast cancer recurrence, second primary breast tumors, and long-term sequelae of their original treatment. Learning more about whether there are preventable factors that influence the sequelae of outcomes will help us with the secondary prevention of breast cancer and will lead to a reduction in morbidity.

Research at Group Health Cooperative (GHC) is supported by extensive automated clinical data systems, including routine linkage between GHC enrollment files and the Western Washington Surveillance Epidemiology and End Results registry. GHC investigators also have access to a large patient population and automated data systems. Care can be tracked from in- and out-patient visits to primary and specialty providers, hospital stays, prescription drug fills, radiology, and results of lab tests (including biopsy data for benign and malignant lesions). The two longitudinal observational studies described in this application are designed to provide Dr. Buist with experience in breast cancer treatment (projects 1 & 2), breast pathology and prognostic factors (project 1), and quality of breast cancer care (project 2). Both studies in this application take advantage of an array of computerized data systems and medical records at GHC to follow two cohorts of women with breast cancer from their date of their diagnosis for 5 years (project 2) and 10 years (project 1) to ascertain breast cancer outcomes, specifically recurrence and mortality (breast cancer specific and all-cause).

The proposed mentored research and educational program outlined in this application will facilitate Dr. Buist’s growth and maturation as an academic researcher and will play a critical role in her understanding of traditional therapies for breast cancer. At the end of this three-year award, Dr. Buist will have gained experience in appropriately measuring breast cancer treatment in an observational setting, biologic characteristics of tumors, and quality of cancer care. Each of these will be essential for incorporating disease-free survival as an endpoint in epidemiologic studies and for building a successful independent research program focused on reducing morbidity and mortality from breast cancer. Upon completion of this grant, she will also have gained an understanding of where the fields of prognostic factors and breast cancer-free survival are, where observational data could best be used to track long- and short-term outcomes of breast cancer, and she will have a good understanding of where HMO research could best contribute to the field. The purpose of this application is not solely to seek answers to novel research questions, but also to build infrastructure and collaborative ties with multi-disciplinary researchers in the scientific community who will help Dr. Buist develop a successful independent research program in breast cancer control and secondary prevention.

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Medication Use and Risk of Esophageal Adenocarcinoma & Barrett's Esophagus Direct link to this project

Project Staff:
  • Project Leader: Larry Engel, Memorial Sloane Kettering Cancer Center
  • Investigator: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Gene Hart, Group Health
  • Investigator: Joan Fortuny, Catalan Institute of Oncology
  • Investigator: Kari Bohlke, Group Health
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 9/18/2002

Area(s) of Research: Biology & Etiology; Epidemiology & Surveillance

Description: minus sign Hide

Esophageal adenocarcinoma has increased sharply in incidence in the United States and western Europe over the past few decades. In contrast, the incidence rate for esophageal squamous cell carcinoma which, prior to the 1990s, accounted for the majority of esophageal cancers, has remained stable or decreased during that time. The incidence rate of esophageal adenocarcinoma differs by race and gender. Among white males, the incidence has increased more than 350% since the mid-1970s. Incidence has increased among black males, but much less markedly and the rate remains at approximately one-fifth the level of white males. Incidence of this cancer has increased to a similar extent among females, but the rate remains much lower than for males.

The rapid increase in the incidence of this cancer among some populations suggests an increase in the prevalence of some risk factors in recent decades. While certain risk factors have been identified, much of the increasing trend remains unexplained. Although still relatively uncommon, the poor prognosis for esophageal adenocarcinoma lends urgency to efforts to identify risk factors.

A large proportion of esophageal adenocarcinomas occur in persons with a history of gastroesophageal reflux. This acid reflux is believed to cause metaplasia of the esophagus, a condition known as Barrett's esophagus, which can lead to adenocarcinoma. Several common medications can increase gastroesophageal reflux by reducing pressure in the lower esophageal sphincter (LES) or by impairing esophageal motility. These medications may be contributing to the increasing incidence of esophageal adenocarcinoma through their effects on LES pressure or esophageal motility and their rising prevalence of use.

The overall objective of this epidemiologic study is to determine whether certain prescribed medications are risk factors for esophageal adenocarcinoma or Barrett's esophagus. The specific aims are to examine:

  1. The risks of esophageal adenocarcinoma and Barrett's esophagus in relation to the use of medications that relax the lower esophageal sphincter (LES).
  2. The associations of esophageal adenocarcinoma and Barrett's esophagus with the use of prescription non-steroidal anti-inflammatory drugs, which may be protective for these diseases.
  3. The associations between esophageal adenocarcinoma and certain medical conditions such as Barrett's esophagus and gastroesophageal reflux disease (GERD).

This is the Pilot Phase of a planned two-phase case-control study involving two CRN health plan members, Group Health Cooperative and Henry Ford Health System. In Phase I, computerized records were used to identify persons diagnosed with either esophageal cancer or Barrett's esophagus. These cases will be compared to controls on the use of certain categories of medication as well as individual medications within those categories. Computerized pharmacy records will be utilized to examine not only of whether a subject used a given medication, but also the prescribed dose, frequency of prescription refills, and duration of use. Esophageal adenocarcinoma cases will also be compared to controls for a history of selected medical conditions, including Barrett's esophagus. Although Phase I will rely primarily on computerized records for data acquisition, a medical chart abstraction form will also be developed and pilot tested to help evaluate the availability from medical records of information on potential co-variates and confounding variables.

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Evaluation of End-of-Life Care for Prostate Cancer in the Managed Care Environment Direct link to this project

Project Staff:
  • Project Leader: Lori Armstrong, Center for Disease Control

Funding Source: Centers for Disease Control
Funding Start Date: 1/1/2002

Area(s) of Research: Health Services

Phase(s) of Care: End of Life

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The objective of this study was to examine different factors affecting care for terminally ill prostate cancer patients. Medical record abstraction was the primary data collection modality. Data were collected on 300 prostate cancer deaths. We learned that collecting hospice data from our internal hospices created challenges. We also learned that the rate of hospice use among men dying of prostate cancer exceeded 80%, but the length of stay in hospice was only 5 weeks.

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Evaluation of Hospice Referral and Palliative Care for Ovarian Cancer in the Managed Care Environment Direct link to this project

Project Staff:
  • Investigator: Cheri Rolnick, HealthPartners Research Foundation
  • Investigator: Lisa Herrinton, KP Northern California
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Steve Coughlin, Center for Disease Control

Funding Source: Centers for Disease Control
Funding Start Date: 1/1/2002

Area(s) of Research: Health Services; Outcomes; Quality of Care

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The objective of this CDC task order was to describe end of life symptoms, care and factors that may be associated with care (or lack of it) for women who die of ovarian cancer. An important goal of this study was to examine end-of-life care among a group of these patients who are diverse in terms of race, ethnicity, socioeconomic status, and geographic location. A special focus of this project was the experience of end-of-life care in managed care organizations where patients have comprehensive health insurance coverage for physicians' services, hospital care, emergency room care, surgical procedures, radiology procedures, laboratory tests, prescribed drugs, home health care, and hospice care.

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Patient-Oriented Outcomes of Prophylactic Mastectomy Direct link to this project

Project Staff:
  • Project Leader: Ann Geiger, Wake Forest University
  • Investigator: Andrea Altschuler, KP Northern California
  • Investigator: Cheri Rolnick, HealthPartners Research Foundation
  • Investigator: Emily Harris, KP Northwest
  • Investigator: Joann Elmore, University of Washington
  • Investigator: Larissa Nekhlyudov, Harvard Pilgrim Health Care
  • Investigator: Lisa Herrinton, KP Northern California
  • Investigator: Sarah Greene, Group Health
  • Investigator: Suzanne Fletcher, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2002

Area(s) of Research: Outcomes; Quality of Care; Behavior

Phase(s) of Care: Prevention; Survivorship

Description: minus sign Hide

This study, led by Dr. Ann Geiger (Wake Forest University; formerly of KPSC), used the prophylactic mastectomy efficacy study cohort of nearly 800 women who had undergone contralateral prophylactic mastectomy, bilateral prophylactic mastectomy, or neither of these surgeries (comparison group) at six CRN sites. A survey ascertained willingness to recommend prophylactic mastectomy, decision satisfaction, breast cancer risk-related stress, body image, and sexual activity. Most women undergoing prophylactic mastectomy were satisfied with their decision and reported quality of life comparable to similarly at-risk women in the comparison group. Investigators also examined decision-making research questions and contributed methods papers pertaining to medical records data validity and the impact of IRB reviews on study operations and response rates.

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The Impact of Endocrine Therapy on Survival in Men with Local or Regional Prostate Cancer in the Managed Care Environment Direct link to this project

Project Staff:
  • Project Leader: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Feifei Wei, HealthPartners Research Foundation
  • Investigator: Kari Bohlke, Group Health
  • Investigator: Rich Platt, Harvard Pilgrim Health Care
  • Investigator: Stephen K. Van Den Eeden, KP Northern California
  • Investigator: Shelley Enger, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 10/1/2001

Area(s) of Research: Epidemiology & Surveillance; Outcomes

Tumor Site(s): Prostate

Phase(s) of Care: Treatment

Description: minus sign Hide

The purpose of this administrative supplement was to determine whether early use of anti-androgen therapy among men with local or regional prostate cancer has had an effect on survival. This study, led by Dr. Marianne Ulcickas Yood at Yale was conducted among men diagnosed with prostate cancer who are served by four CRN health plans: Group Health, Henry Ford Health System, Kaiser Permanente Northern California, and Kaiser Permanente Southern California. This collaborative effort includes more than 20,000 patients with localized or regional prostate cancer; 15% of whom received early hormonal therapy. This study was designed to efficiently evaluate the association between early hormonal treatment of prostate cancer and mortality by using automated data sources. Ancillary methodologic work performed through this study confirmed that automated data can be used to reliably classify hormone treatment exposure among men diagnosed with prostate cancer, although variability exists across HMO and over calendar time. Further analysis will determine whether a full study of hormone therapy and prostate cancer, using only automated data with these four CRN sites, is warranted and the parameters with which such a study should be undertaken.

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Lung/Colon Cancer Outcomes: The Cancer Research Network Direct link to this project

Project Staff:
  • Project Leader: John Ayanian, Harvard Pilgrim Health Care
  • Investigator: David Nerenz, Henry Ford Health System
  • Investigator: Jane Weeks, Dana Farber Cancer Institute
  • Investigator: Robert Fletcher, Harvard Pilgrim Health Care

Funding Source: National Cancer Institute
Funding Start Date: 9/26/2001

Area(s) of Research: Health Disparities; Health Services; Outcomes; Quality of Care; Behavior

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The Cancer Care Outcomes Research and Surveillance Consortium (CanCORS) aims to improve ways of monitoring the quality of care delivered to patients newly diagnosed with lung or colorectal cancer. CanCORS is examining patterns of care, health outcomes, costs, and patient-centered issues such as symptom control and quality of life. Another aspect of the study measures costs associated with different treatment strategies. Five CRN sites jointly comprise one of the seven Primary Data Collection and Research sites, and collectively the CRN sites contribute data to CanCORS on a total of 2,000 out of the total expected 10,000 patients with these two cancers. With such a large number of diverse patients being treated at different kinds of delivery systems spread across the country, a particular focus is to track variations in care, with an eye toward reducing disparities and ensuring universally excellent care. The CanCORS Web site has additional information about the research process and participating grantees.

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Pilot Study of Disenrollment among HMO Patients with Cancer Direct link to this project

Project Staff:
  • Project Leader: Terry Field, Meyers Primary Care Institute
  • Investigator: Ann Geiger, Wake Forest University
  • Investigator: Diana Buist, Group Health
  • Investigator: Lisa Herrinton, KP Northern California
  • Investigator: Lois Lamerato, Henry Ford Health System
  • Investigator: Mark Hornbrook, KP Northwest
  • Investigator: Sarah Greene, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 8/1/2001

Area(s) of Research: Health Services; Quality of Care

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This study assessed turnover among enrollees with cancer diagnoses in five HMOs and how turnover may affect longitudinal cancer outcomes research. The Principal Investigator, Dr. Terry Field (MPCI), and colleagues studied the retention rates among cancer survivors over a six-year period. Enrollees were followed from diagnosis through death, disenrollment, or end of follow-up. The retention rates among survivors for all cancers combined at one and five years after diagnosis were 96.0 percent and 83.9 percent, respectively. The proportion of enrollees who remained enrolled and available for evaluation suggests that the CRN is well suited for studies of cancer quality of care, survivorship, and long-term outcomes. This led to a follow-up study that assessed racial disparities in cancer care and survival in more than 130,000 cancer patients.

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Enrolling Vietnamese and Chinese Women in Breast Cancer Treatment and Prevention Trials Direct link to this project

Project Staff:
  • Project Leader: Tung Nguyen, University of California San Francisco
  • Investigator: Carol Somkin, KP Northern California

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2001

Area(s) of Research: Health Disparities; Health Services; Interventional

Tumor Site(s): Breast

Phase(s) of Care: Prevention

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This CRN Administrative Supplement explored the barriers preventing the accrual of Asian women in breast cancer treatment and prevention trials from the provider and patient perspectives. In a pilot study to assess barriers to participation, the study team surveyed 132 oncologists and interviewed 19 Asian-American women with cancer from Northern California. Forty-four oncologists responded. Identified barriers include language problems, lack of culturally relevant cancer information, and complex protocols. While most oncologists stated that they informed Asian-American women about treatment trials, only four women interviewed knew about trials. Other patient-identified barriers were fear of side effects, language problems, competing needs, and fear of experimentation. Family involvement in decision making was a barrier for both oncologists and patients. The findings indicate that Asian-American women need better (linguistically appropriate) information about cancer treatment trials, and future research should evaluate cultural barriers such as family decision making.

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Colon cancer survivors: medications and risk of recurrence Direct link to this project

Project Staff:
  • Project Leader: Christine Cole Johnson, Henry Ford Health System
  • Investigator: Cheri Rolnick, HealthPartners Research Foundation
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Sharon Hensley Alford, Henry Ford Health System

Funding Source: National Cancer Institute
Funding Start Date: 9/1/2000

Area(s) of Research: Health Disparities; Health Literacy; Quality of Care

Description: minus sign Hide

Non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal therapy (HT) have been shown to decrease incident colon cancer. Little is known of their effect on persons with a history of colon cancer and presumably at high risk for the development of another malignant lesion—an expanding population of individuals as survival with this disease has been significantly improving over the last twenty years. The objective of the "Colon Cancer Survivors: Medications & Risk of Recurrence" study led by Dr. Christine Johnson (HFHS) is to determine whether NSAIDs or HT are associated with recurrence or survival among individuals with a previous diagnosis of colorectal cancer. A cohort of over 1300 subjects is being followed for at least five years using medical record review, for new evidence of disease, recurrence and survival outcome. Using automated pharmacy data, the timing of use and exposure to NSAIDs and HT will be analyzed among these cancer survivors. Investigators from CRN sites Henry Ford and HealthPartners are collaborating on this study, which was funded as an R01 in Spring 2000. The study provided data for an investigation of racial and age differences in post-treatment surveillance of patients with colorectal cancer.

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Design, Implementation & Analysis of a Clinician Survey (DETECT Supplement) Direct link to this project

Project Staff:
  • Project Leader: Ed Wagner, Group Health
  • Investigator: Carol Somkin, KP Northern California
  • Investigator: Jane Zapka, University of Massachusetts
  • Investigator: Judy Mouchawar, KP Colorado
  • Investigator: Steve Taplin, National Cancer Institute

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2000

Description: minus sign Hide

This administrative supplement allowed the DETECT project team to survey providers in participating health maintenance organizations to provide an analysis of the provider level organizational factors that impact effective cancer screening practices.

Specific aims were:

  1. Document clinician report of implementation of policies related to breast and cervical cancer screening.
  2. Explore congruence of common measures obtained from three data sources (plan policy survey, clinician implementation survey, and patient survey).

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Pilot Study to Identify Organizational Barriers to HMO Participation in Clinical Trials Direct link to this project

Project Staff:
  • Project Leader: Carol Somkin, KP Northern California
  • Investigator: Andrea Altschuler, KP Northern California
  • Investigator: Andy Glass, KP Northwest
  • Investigator: Andy Nelson, HealthPartners Research Foundation
  • Investigator: Ed Wagner, Group Health
  • Investigator: Judy Mouchawar, KP Colorado
  • Investigator: Sarah Greene, Group Health
  • Investigator: Terry Field, Meyers Primary Care Institute

Funding Source: National Cancer Institute
Funding Start Date: 1/1/2000

Area(s) of Research: Health Services; Interventional; Policy; Quality of Care

Phase(s) of Care: Treatment

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Clinical trials are the primary mechanism by which new approaches to cancer treatment can be evaluated, yet only a very small proportion of eligible cancer patients are offered the opportunity to participate in clinical trials, and fewer actually enroll. Dr. Carol Somkin (KPNC) investigated attitudinal and organizational barriers to clinical trial participation at multiple CRN sites in a pilot study. The study revealed enthusiasm for clinical trials, but also a critical need for infrastructure to support trials, better intra-organizational communication, and consideration of a trial design’s impact on health plan resources. The study team next received a larger grant to increase patient participation in clinical trials, known as CHOICES: Understanding Clinical Trials as a Treatment Option. This study will use a cluster randomized trial to evaluate the effectiveness of a telephone counseling intervention to increase enrollment, knowledge, and satisfaction with treatment decision. The intervention will be tailored to patient language (English and Spanish), ethnic and cultural background, knowledge, attitudes, and beliefs about clinical trials.

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Detecting Early Tumors Enables Cancer Therapy Direct link to this project

Project Staff:
  • Project Leader: Steve Taplin, National Cancer Institute
  • Investigator: Ann Geiger, Wake Forest University
  • Investigator: Carol Somkin, KP Northern California
  • Investigator: Jane Zapka, University of Massachusetts
  • Investigator: Joyce Gilbert, KP Hawaii
  • Investigator: Judy Mouchawar, KP Colorado
  • Investigator: Leif Solberg, HealthPartners Research Foundation
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System
  • Investigator: Michele Manos, KP Northern California
  • Investigator: Sheila Weinmann, KP Northwest
  • Investigator: Wendy Leyden, KP Northern California
  • Investigator: William Barlow, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 6/1/1999

Area(s) of Research: Health Services; Quality of Care

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This eight-HMO project, led by Dr. Stephen Taplin (NCI; formerly of GHC), identified women with invasive cervical cancer or late-stage breast cancer. The project estimated the proportion of each group attributable to potential problems in care delivery—absence of screening and detection and/or deficiencies in follow-up. The project team created a model for considering quality issues in cancer care. They also profiled the screening practices and policies in the HMOs and surveyed clinician attitudes about screening policies and practices. The absence of screening accounted for most of the late-stage breast and cervical cancers.

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HMOs Investigating Tobacco Direct link to this project

Project Staff:
  • Project Leader: Victor Stevens, KP Northwest
  • Investigator: Brian Hazlehurst, KP Northwest
  • Investigator: Dean Sittig, KP Northwest
  • Investigator: Debra Ritzwoller, KP Colorado
  • Investigator: Jack Hollis, KP Northwest
  • Investigator: Jane Zapka, University of Massachusetts
  • Investigator: Jennifer Elston-Lafata, Henry Ford Health System
  • Investigator: Jonathan Winickoff, Harvard Pilgrim Health Care
  • Investigator: Leif Solberg, HealthPartners Research Foundation
  • Investigator: Michael Maciosek, HealthPartners Research Foundation
  • Investigator: Nancy Gordon, KP Northern California
  • Investigator: Nancy Rigotti, Harvard Pilgrim Health Care
  • Investigator: Paul Fishman, Group Health
  • Investigator: Russ Glasgow, KP Colorado
  • Investigator: Ted Palen, KP Colorado
  • Investigator: Thomas Vogt, KP Hawaii
  • Investigator: Virginia Quinn, KP Southern California

Funding Source: National Cancer Institute
Funding Start Date: 6/1/1999

Area(s) of Research: Informatics; Quality of Care; Behavior

Description: minus sign Hide

This CRN 1 study examined tobacco policies and delivery of cessation services in nine non-profit HMOs that collectively provide comprehensive medical care to more than eight million members. Three annual surveys with health plan managers showed that all of these organizations had written tobacco control guidelines that became more comprehensive over the span of the study. The project also surveyed a random sample of 4,207 current smokers who had attended a primary care visit in the past year (399 to 528 at each of nine health plans). Of these smokers, 71 percent reported receiving advice to quit, 56 percent were asked about their willingness to quit, 49 percent were provided some assistance in quitting (mostly self-help material or information about classes or counseling), and 9 percent were offered some kind of follow-up. Smokers receiving assistance in quitting reported higher satisfaction with their care. In general, health plans with the most comprehensive policies also showed higher rates of implementing tobacco treatment programs in primary care.

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Program Testing Early Cancer Treatment and Screening Direct link to this project

Project Staff:
  • Project Leader: Suzanne Fletcher, Harvard Pilgrim Health Care
  • Investigator: Ann Geiger, Wake Forest University
  • Investigator: Cheri Rolnick, HealthPartners Research Foundation
  • Investigator: Emily Harris, KP Northwest
  • Investigator: Jane Zapka, University of Massachusetts
  • Investigator: Joann Elmore, University of Washington
  • Investigator: Lisa Herrinton, KP Northern California
  • Investigator: William Barlow, Group Health

Funding Source: National Cancer Institute
Funding Start Date: 6/1/1999

Area(s) of Research: Epidemiology & Surveillance; Health Services; Outcomes; Quality of Care

Tumor Site(s): Breast

Phase(s) of Care: Screening

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This project, led by Dr. Suzanne Fletcher (HPHC), evaluated the efficacy of bilateral prophylactic mastectomy (BPM) and contralateral prophylactic mastectomy (CPM) among women with unilateral breast cancer in reducing subsequent breast cancer incidence and mortality, compared to women who had not undergone these surgeries. The women who underwent BPM had a significant reduction in breast cancer risk, but approximately two-thirds experienced significant adverse effects. Compared with breast cancer patients without CPM, the risk of contralateral breast cancer in these women was also reduced significantly. The project also evaluated the efficacy of mammography and clinical breast exam in real-world settings and contributed methodologic innovations and analyses.

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Investigating Medical Patient Records & Administrative Data in Case Identification & Treatment Direct link to this project

Project Staff:
  • Project Leader: Terry Field, Meyers Primary Care Institute
  • Investigator: Charles Quesenberry, KP Northern California
  • Investigator: Cheri Rolnick, HealthPartners Research Foundation
  • Investigator: Chyke Doubeni, Meyers Primary Care Institute
  • Investigator: Feifei Wei, HealthPartners Research Foundation
  • Investigator: Jerry Gurwitz, Meyers Primary Care Institute
  • Investigator: Marianne Ulcickas Yood, Henry Ford Health System

Funding Source: National Cancer Institute
Area(s) of Research: Epidemiology & Surveillance; Health Services

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Background

The purpose of this study is to identify the existence and extent of biases associated with HMO full electronic and claims-type encounter data when they are used to characterize patterns of care and to analyze the relationship between treatment and outcomes of breast and cervical cancers. Electronic data assessed will include inpatient and outpatient visits, pharmacy, cancer registry, pathology, radiology, laboratory, and electronic physician notes. This project is a joint venture between four members of the HMO Cancer Research Network: Fallon/Meyers Primary Care Institute (Fallon) on the East Coast, Kaiser Permanente - Northern California (KPNC) on the West Coast, HealthPartners Research Foundation (HPRF), and Henry Ford Health System (HFHS) in the Midwest.

Study Aims

The goal of this project is to determine the completeness and accuracy of HMO comprehensive electronic data systems to identify breast and cervical cancer patients, treatment received, and delivery system factors associated with differences in outcomes. Electronic data assessed will include inpatient and outpatient visits, pharmacy, cancer registry, pathology, radiology, laboratory, and electronic physician notes. We will also take advantage of the opportunity to assess the usefulness of claims-type encounter data alone for tracking patterns of care and outcomes. The specific aims of this project are to:

  1. Determine the completeness and accuracy of full HMO electronic data, including inpatient and outpatient claims as well as pharmacy, cancer registry, pathology, radiology, laboratory and physician notes data for identifying cancer patients, disease stage, treatment and outcomes among women age 55 or older with breast cancer and women of any age with cervical cancer.
  2. Determine the completeness and accuracy of inpatient and outpatient claims-type encounter data alone for tracking treatment and outcomes among women age 55 or older with breast cancer and women of any age with cervical cancer.
  3. Analyze variations in completeness and accuracy of these data by patient characteristics and among different HMO's.
  4. Identify the existence and extent of biases associated with claims-type encounter and full electronic data when they are used to characterize patterns of care and to analyze the relationship between treatment and outcomes for women age 55 or older with breast cancer and women of any age with cervical cancer.

Methods

The study will compare information in the electronic data sources to information abstracted from medical records, and assess differences in completeness and accuracy of diagnostic, treatment, and outcomes by patient characteristics, among HMOs, and by source of data. Medical records of randomly sampled cancer patients from all four HMOs, stratified by the age of patient and clinical stage of cancer, will be audited to assess the accuracy and completeness of full electronic and claims-type encounter data on diagnosis, cancer stage, treatment, comorbidities, and outcome. Breast Cancer: A total of 925 women with breast cancer will be randomly selected for the chart audit. From these cases, 500 patients will be sampled from HMOs with cancer registries and the other 425 from sites without cancer registries. They will be selected within categories of age and stage of cancer from the breast cancer study population, assembled through claims-type encounter and full HMO electronic data. Cervical Cancer: Similarly, 995 women with cervical cancer will be randomly selected for the chart audit. Among these cases, 350 patients will be obtained from an HMO with cancer registries and the other 645 from HMOs without cancer registries.

Significance

This study will provide important information about the feasibility of using computerized claims data as well as other computerized resources for the study of cancer treatment and outcomes. The primary strength of the study is that it uses routinely and efficiently collected population-based electronic data to identify cancer patients, treatments, and outcomes. If these databases are shown to be valid, they provide promising resources for cancer studies with extensive information on treatment, follow-up, and outcome far exceeding those available from traditional cancer registries.

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