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Michigan Center for Health Communications Research Direct link to this project

Principal Investigator: Vic Strecher; University of Michigan
Funding Source: National Cancer Institute
Funding Start Date: 2003-09-26
Area(s) of Research: Communication; Outcomes; Behavior
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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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Development of a Versatile Geospatial Database within the CRN Direct link to this project

Principal Investigator: Andrea Cook; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
Area(s) of Research: Informatics
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Geographic information associated with health records and facilities has been shown to have a broad range of applications to health services research, such as: 1. examining associations of area-level data including race and socioeconomic measures with health outcomes, 2. calculation geographic access to health services, 3. examination of service areas for healthcare systems, and 4. measurement of geographically-based exposures. Geocoding address data to a spatial unit that preserves enough location information, while also having spatially congruent demographic data is a challenge for data use and sharing among health care organizations and researchers, and thus has limited the full potential of data resources, particularly when linking to health care utilization and outcome data. Currently, each CRN site captures geographic information from its members and has geocoded these data with varying degrees of completeness, spatial resolution, and timeliness. Facility-level geocoding is lacking within the CRN, but would allow development of service areas with which to characterize member access and utilization. This project will expand the existing geocoding infrastructure to create a versatile geospatial database that will include individual, demographic, and facility-level geographic variables which can be used across the CRN to expand its research potential. We will demonstrate the utility by testing hypotheses with this geospatial database that relate demographics and spatial access with cancer care.

The four primary aims of the pilot study are: Aim 1: Develop and implement a new process for geocoding location information and associating it with contextual demographics. Aim 2: Define the necessary steps required in the IRB process to implement data sharing of geocoded data for analyses and reporting across CRN sites and with investigators external to the CRN. Aim 3: Geocode facilities from the pilot site within the HMO Research Network and derive service areas based on travel time. Aim 4: Use the geocoded facility and member data to examine the influence of travel time, facility availability, and socioeconomic indicators, on receipt of surveillance mammography. The results from this study will provide a framework within the CRN to be able to link member data to spatial locations and relate those locations to contextual demographics, such as area socioeconomic and distance to services. We will exemplify the usefulness of this approach by evaluating the relationship of receipt of surveillance mammography to travel time to facility, facility availability, and area socioeconomic indicators.

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

Principal Investigator: Suzanne Fletcher; Harvard Pilgrim Health Care
Funding Source: National Cancer Institute
Area(s) of Research: Epidemiology & Surveillance; Health Services; Outcomes; Quality of Care
Tumor Site(s): Breast
Phases(s) of Care: Screening
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Project PROTECTS, a CRN 1 core project, evaluated the efficacy of bilateral prophylactic mastectomy (BPM) among women at high risk of developing breast cancer, and of contralateral prophylactic mastectomy (CPM) among women with unilateral cancer, in reducing subsequent breast cancer incidence and mortality. The 269 women who underwent BPM had a significant reduction in breast cancer risk, but approximately 2/3 experienced significant adverse effects. The retrospective cohort study of CPM, conducted in six CRN sites, identified 53,200 women age 18–80 years at diagnosis who developed unilateral breast cancer during 1979–1999. Of these, 1,074 women had CPM. Compared with a sample of 349 women without CPM, these women reduced their risk of contralateral breast cancer by 90 percent. After adjusting for breast cancer characteristics and treatment, the hazard ratios for the relationship of CPM to death from breast cancer, other causes, and all causes were 0.57, 0.78, and 0.60, respectively. The project also evaluated the efficacy of mammography and clinical breast exam in real-world settings. Among their methodologic contributions, this project team developed a computerized approach to medical record abstraction, which has been used in other CRN projects, and also examined the impact of multiple Institutional Review Board (IRB) reviews on the implementation of the study.

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HMOs Investigating Tobacco Direct link to this project

Principal Investigator: Victor Stevens; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 1999-06-01
Area(s) of Research: Health Services; Informatics; Quality of Care; Behavior
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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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Detecting Early Tumors Enables Cancer Therapy Direct link to this project

Principal Investigator: Steve Taplin; National Cancer Institute
Funding Source: National Cancer Institute
Funding Start Date: 1999-06-01
Area(s) of Research: Health Services; Quality of Care
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This eight-site CRN 1 project identified 1,347 women with late-stage breast cancer and 833 with invasive cervical cancer. The project estimated the proportion of each group attributable to potential problems in care delivery: absence of screening and detection and deficiencies in follow-up. The project team created a model for considering quality issues in cancer care. They also profiled the screening practices, policies, and operational procedures in the eight HMOs and surveyed clinician attitudes about screening policies and practices. For both breast and cervical cancer, the absence of screening accounted for most of the failures. The team also identified the characteristics of women among this insured population who were not screened or refused follow-up treatment. Older women were over-represented in both groups, and those refusing treatment tended to have more advanced cancer. Another analysis sought—and did not find—missed clinical opportunities for detection in women with advanced disease whose mammograms were normal. A methodologic comparison of patient self-report data with medical record data showed good congruence when patients reported receiving mammography, but lower congruence for receiving Pap tests. The team also published papers on methods to optimize implementation of physician surveys.

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

Principal Investigator: Lori Armstrong; Center for Disease Control
Funding Source: Centers for Disease Control
Area(s) of Research: Health Services; Outcomes
Tumor Site(s): Prostate
Phases(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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Pilot Study to Identify Organizational Barriers to HMO Participation in Clinical Trials Direct link to this project

Principal Investigator: Carol Somkin; KP Northern California
Funding Source: National Cancer Institute
Funding Start Date: 2000-01-01
Area(s) of Research: Health Services; Interventional; Policy; Quality of Care
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This study used surveys and semi-structured interviews to investigate attitudinal and organizational barriers to clinical trial participation. A self-administered survey to oncologists at 10 CRN sites was fielded in 2001; 198 completed questionnaires were received, with an response rate of 90 percent. The team also conducted key informant interviews with health plan and oncology leaders at 9 CRN sites to explore extant strategies and barriers to plan member participation in cancer trials. The survey results revealed considerable enthusiasm for clinical trials, but also a critical need for infrastructure to support trials, especially additional support staff and research nurses. In addition, the need was expressed for better intra-organizational communication and consideration of the impact of trial design on internal health plan resources. This work led to a recent NCI R01 grant award for Dr. Somkin’s team to evaluate the effectiveness in increasing clinical trial participation of a tailored telephone counseling intervention for patients in addition to a system to notify oncologists about their potentially trial-eligible patients.

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Design, Implementation & Analysis of a Clinician Survey Direct link to this project

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2000-01-01
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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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Lung/Colon Cancer Outcomes: The Cancer Research Network Direct link to this project

Funding Source: National Cancer Institute
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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Patient-Oriented Outcomes of Prophylactic Mastectomy Direct link to this project

Principal Investigator: Ann Geiger, MPH, PhD; Wake Forest University
Funding Source: National Cancer Institute
Funding Start Date: 2002-01-01
Area(s) of Research: Outcomes; Quality of Care; Behavior
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Using the extant prophylactic mastectomy efficacy study cohort of nearly 800 women at six CRN sites (GHC, HPHC, HPRF, KPNC, KPNW and KPSC), the study gathered both quantitative and qualitative data from women who had undergone either contralateral prophylactic mastectomy (CPM) or bilateral prophylactic mastectomy (BPM), along with a comparison group of a random sample of women with breast cancer who had not undergone the procedure. A mailed survey ascertained: willingness to recommend prophylactic mastectomy; decision satisfaction; breast cancer risk-related stress; body image; and sexual activity. The majority of women undergoing prophylactic mastectomy were satisfied with their decision and reported contentment with their quality of life that was comparable to similarly at-risk women who had not had prophylactic mastectomy. Investigators also examined decision-making roles and what women wished they had known prior to the procedure. The study contributed methods papers on the validity of race prior to ethnicity data in medical records, and the impact of multiple IRB reviews on study operations and response rates. Collectively, these data provide a rich picture impact of women’s medical and emotional needs as they undertake this profound decision.

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

Principal Investigator: Christine Cole Johnson; Henry Ford Health System
Funding Source: National Cancer Institute
Funding Start Date: 2000-09-01
Area(s) of Research: Health Disparities; Health Literacy; Quality of Care
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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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Investigating Medical Patient Records & Administrative Data in Case Identification & Treatment Direct link to this project

Principal Investigator: Terry Field; Meyers Primary Care Institute
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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Pilot Study of Disenrollment among HMO Patients with Cancer Direct link to this project

Principal Investigator: Terry Field; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2001-08-01
Area(s) of Research: Health Services; Quality of Care
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The pilot study was conducted through an administrative supplement to assess turnover among HMO enrollees with cancer diagnoses—and how it may affect longitudinal cancer research. The Principal Investigator, Dr. Terry Field (MPCI), and colleagues studied the retention rates among survivors of the 132,580 patients diagnosed with cancer from January 1, 1993 through December 31, 1998 who were enrolled at five CRN HMOs. Enrollees were followed from cancer diagnosis through death, disenrollment, or the end of follow-up (December 31, 1999). The retention rate among survivors for all cancers combined at 1 and 5 years after cancer diagnosis was 96.0 percent and 83.9 percent, respectively. The proportion of enrollees diagnosed with cancer who remained enrolled and available for evaluation suggests that the CRN is well-suited for studies of the quality of care for cancer patients, survivorship, and long-term outcomes. This study led to the CRN Cancer Outcomes Cohort 1993 – 1998 Study that has published two manuscripts, both focused on racial disparities in cancer care and survival.

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

Principal Investigator: Tung Nguyen; University of California San Francisco
Funding Source: National Cancer Institute
Funding Start Date: 2001-01-01
Area(s) of Research: Health Disparities; Health Services; Interventional
Tumor Site(s): Breast
Phases(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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The Impact of Endocrine Therapy on Survival in Men with Local or Regional Prostate Cancer-Feasibility Study Direct link to this project

Principal Investigator: Marianne Ulcickas Yood; Henry Ford Health System
Funding Source: National Cancer Institute
Funding Start Date: 2001-10-01
Area(s) of Research: Epidemiology & Surveillance; Outcomes
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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HRT Initiation & Cessation after WHI Results Direct link to this project

Principal Investigator: Diana Buist; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2005-03-01
Area(s) of Research: Dissemination & Diffusion; Epidemiology & Surveillance; Health Services; Policy; Behavior
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On May 31, 2002, the Data and Safety Monitoring Board stopped the Women’s Health Initiative (WHI) hormone therapy (HT) randomized trial (EPT vs. placebo for women with an intact uterus) after an average of 5•2 years of follow up (2 ½ years early) because the risks of HT were found to outweigh the benefits42. Women randomized to 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. We examined woman-level data from 169,586 women aged 40-80 years from 5 CRN HMOs to estimate overall and age-specific EPT and estrogen-only therapy (ET) prevalence (proportion of women using hormones in the study population) and rates of discontinuation (rate of stopping hormone use among hormone users) and initiation (rate of starting hormones among women who do not use hormones) in the 2 years before the published results of WHI’s EPT trial and for five months after their release.

This study provided important information on the rapid translation of the WHI results into clinical practice (Figure 4, Table C.7.). We were able to identify important patterns of use by age, type of HT 19, comorbidity20, and socio-economic status (SES) factors21.

We are currently in the process of identifying predictors of first time initiation to monitor whether use is occurring according to current clinical recommendations and patterns of re-initiation after cessation (Table C.8.). We have found overall rates of initiation are low; however, women with cardiovascular disease (a group for whom HT use is contraindicated) are more likely to initiate hormone therapy after WHI than women without comorbidities. Importantly, we are finding women who stop and then re-initiate are more likely to restart at a lower dose (Table C.8.). These findings demonstrate the CRN’s ability to rapidly examine changes in therapies over time. We are also currently conducting analyses of the cost implications associated with changes in HRT use, other pharmaceutical therapies employed after HRT cessation, and changes in provider visit rates associated with the published results of WHI’s EPT trial.

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

Funding Source: Centers for Disease Control
Area(s) of Research: Health Services; 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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Medication Use and Risk of Esophageal Adenocarcinoma & Barrett’s Esophagus Direct link to this project

Principal Investigator: Larry Engel, PhD; Memorial Sloane Kettering Cancer Center
Funding Source: National Cancer Institute
Funding Start Date: 2002-09-18
Area(s) of Research: Biology & Etiology; Epidemiology & Surveillance
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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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Breast Cancer Treatment Effectiveness in Older Women Direct link to this project

Principal Investigator: Rebecca Silliman, MD, PhD; Boston University Medical Center
Funding Source: National Cancer Institute
Funding Start Date: 2003-02-01
Area(s) of Research: Epidemiology & Surveillance; Health Disparities; Health Services; Outcomes; Quality of Care
Tumor Site(s): Breast
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Dr. Rebecca Silliman at Boston University 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, longterm surveillance, and recurrence and mortality outcomes. The study compared the effectiveness of different treatment and surveillance patterns, and identified the characteristics of providers, tumors,and patients associated with various treatment choices. Findings confirm that increasing age is associated with lower probability of receiving recommended therapy, and with worse survival.

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

Principal Investigator: Laurie Habel; KP Northern California
Funding Source: National Cancer Institute
Funding Start Date: 2003-03-01
Area(s) of Research: Biology & Etiology; Epidemiology & Surveillance
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In this CRN 2 core project led by Dr. Laurel Habel (KPNC), investigators at three CRN sites (KPSC, HPHC, and KPNC) are studying clinical and pathologic factors that could be used to accurately identify DCIS patients at high and low risk of a recurrence. From medical records, investigators have identified DCIS patients (n=3,700) diagnosed between 1990 and 2001, treated with breast conserving surgery (BCS) and followed for recurrence. Standardized reviews of diagnostic slides from the initial tumors of cases and controls have been completed by collaborating expert pathologists at Beth Israel Deaconess Medical Center. Immunohistochemistry testing for several markers also has been completed. Initial results indicate that presence of flat epithelial atypia (FEA) is associated with several pathologic features in DCIS. Preliminary data indicate that rates of recurrence after BCS for DCIS have been declining as treatment with adjuvant radiotherapy and tamoxifen have increased; use of adjuvant treatment does not appear to differ markedly across racial/ethnic groups; and surveillance mammography after BCS for DCIS declines over time and becomes inadequate. This is the largest and most comprehensive study to date on prognostic factors for DCIS, and will improve our understanding of the natural history of DCIS and help in the development of individually tailored treatment strategies for patients with DCIS. This study also serves as a model of a CRN project that leverages the unique electronic and biologic data available in the CRN health plans.

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Making Effective Nutritional Choices Direct link to this project

Principal Investigator: Christine Cole Johnson; Henry Ford Health System
Funding Source: National Cancer Institute
Funding Start Date: 2003-01-01
Area(s) of Research: Communication; Behavior
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This CRN 2 core study, led by Dr. Christine Cole Johnson (HFHS), developed and evaluated an individually tailored, Web-based program to promote daily fruit and vegetable (F&V) consumption. Focus groups and a preliminary enrollment/retention study tested the feasibility of a Web-based dietary intervention program. The efficacy of the intervention was tested in a multi-site, randomized trial involving five CRN HMOs. The three strategies tested in the trial were: untailored Web program, tailored Web program, and tailored Web program plus email support. A diverse sample of adults enrolled (n=2,540), and the online intervention was shown to be effective. All three intervention arms

showed early and sustained increase of more than two servings of F&V, on average. The untailored Web program arm was less effective than either the tailored arm or tailored plus email support arm. Across arms, those participating online at a higher rate had more gain in F&V servings, the retention rate was high (>80% at 12 months) and reported satisfaction with the online program was high. Further analyses will explore the effect of participants’ demographic characteristics, family history of cancer, and stage of change on dietary behaviors at 3, 6, and 12 months.

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

Principal Investigator: Victor Stevens; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2003-03-11
Area(s) of Research: Health Services; Informatics; Quality of Care; Behavior
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Electronic medical records (EMRs)offer an attractive method for evaluating guideline implementation and improving quality of care for entire patient populations. This CRN 2 study (HIT2), led by Dr. Victor Stevens of Kaiser Permanente Northwest, developed a method for coding tobacco cessation activities(the “Five A’s”)in four HMOs using EMRs. In addition to data from coded fields (e.g., check boxes, standardized diagnosis and treatment codes, and prescriptions), information entered in free-text fields (e.g., progress notes) was coded using MediClass,a natural language processing program. The HIT2 investigator team evaluated the accuracy of MediClass in assessing whether clinicians adhered to the national tobacco treatment guidelines (the “Five A’s”) with patients. Specially trained medical records abstractors at each of the four participating HMOs manually coded 500 records according to whether or not each of the five guidelines for smoking cessation care were addressed during routine outpatient visits. For each patient’s record, they compared the presence or absence of each of the guidelines as assessed by each human coder and by MediClass. MediClass performed as well as the human abstractors and was found to be a practical method for assessing adherence to the tobacco treatment guidelines in primary care.

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

Principal Investigator: Diana Buist; Group Health
Funding Source: American Cancer Society
Funding Start Date: 2003-01-01
Tumor Site(s): Breast
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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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Patterns of Preventive Services Utilization of Cancer Survivors (Research Supplement for Underrepresented Minorities Program) Direct link to this project

Principal Investigator: Chyke Doubeni; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2004-04-01
Area(s) of Research: Epidemiology & Surveillance; Health Disparities
Phases(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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HIT2 Supplement Direct link to this project

Funding Source: National Cancer Institute
Funding Start Date: 2004-03-01
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Administrative supplement to provide additional programming time for two sites of the CRN that have encountered difficulties due to system changes.

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Medications and Colorectal Cancer Risk Direct link to this project

Principal Investigator: Denise Boudreau, PhD; Group Health
Funding Source: Agency for Healthcare Research and Quality
Funding Start Date: 2004-08-01
Area(s) of Research: Epidemiology & Surveillance
Tumor Site(s): Colorectal
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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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Statins & Risk of Site-specific Cancers Direct link to this project

Principal Investigator: Denise Boudreau, PhD; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2004-04-27
Area(s) of Research: Epidemiology & Surveillance
Tumor Site(s): Breast ; Prostate ; Other
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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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Investigation of Age-specific Differences & Cancer of the Cecal Colon Direct link to this project

Principal Investigator: Steven Dudas; Henry Ford Health System
Funding Source: National Cancer Institute
Funding Start Date: 2004-03-01
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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Do Acute and Chronic Illness Trump Preventive Care? A Case Study of Breast and Colon Cancer Screening Direct link to this project

Principal Investigator: Josh Fenton, MD, MPH; University of California Davis Medical Center
Funding Source: National Cancer Institute
Funding Start Date: 2004-03-01
Tumor Site(s): Breast
Phases(s) of Care: Screening; Prevention
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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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Accuracy of Automated Data on Colorectal Cancer Screening Direct link to this project

Principal Investigator: Reina Haque; KP Southern California
Funding Source: National Cancer Institute
Funding Start Date: 2004-01-01
Tumor Site(s): Colorectal
Phases(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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African American Disparities in Lung Cancer Direct link to this project

Principal Investigator: Martin Tammemagi; Henry Ford Health System
Funding Source: National Cancer Institute
Funding Start Date: 2004-03-01
Area(s) of Research: Epidemiology & Surveillance; Health Disparities
Tumor Site(s): Lung
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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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Anti-estrogen Therapies for Breast cancer Direct link to this project

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Area(s) of Research: Dissemination & Diffusion; Epidemiology & Surveillance
Tumor Site(s): Breast
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Several randomized trials published in the last 3-4 years have suggested important changes in the routine management of women with estrogen receptor positive breast cancer. This prompted a group of CRN investigators to study the use over time of aromatase inhibitors and tamoxifen among CRN sites. We used this as an opportunity to examine the extent to which CRN organizations tried to standardize cancer treatment. The aromatase inhibitors diffusion study analyses were conducted as part of the diffusion program in CRN2 and contained two parts – an oncologist survey to assess whether and how CRN organizations and oncology groups made policy decisions about cancer interventions; and an analysis of diffusion of aromatase inhibitors among women with estrogen receptor positive breast cancer using automated pharmacy data from seven CRN sites.

Oncologist Survey

We collected data via a two-page survey covering the following topics: 1) whether and how oncologists standardize treatment protocols at their site; 2) cancers for which they use specific guidelines; 3) expectations about guideline adherence by front-line oncologists; and 4) how oncologists prescribe aromatase inhibitors. Among 13 oncology chiefs, seven (from 7 sites) stated that their site had formal treatment guidelines; six (from 4 sites; 2 sites had more than 1 chief) did not. The majority of oncology chiefs said they participated in cooperative clinical research groups and tumor boards or conferences to develop standard guidelines. Four sites had standard treatment protocols for estrogen receptor positive (ER+) invasive breast cancer. 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.

Aromatase Inhibitor Use based on Automated Data

From cancer registry data in the VDW, we identified 13,245 women >55 years with invasive, estrogen receptor positive (ER+) breast cancer diagnosed at seven CRN sites between 1996-2003. We examined use of aromatase inhibitors and tamoxifen from electronic pharmacy data. Just over a quarter (26.6%) of women had ever had a prescription for aromatase inhibitors through 2004. Regardless of whether sites had formal guidelines, these women were more likely to be younger and diagnosed with breast cancer at a later stage compared to women who had not used aromatase inhibitors (Figure 3). Overall, adjuvant anti-estrogen therapy use (aromatase inhibitors or tamoxifen) at any point after diagnosis was greater in sites without formal treatment guidelines compared to sites with guidelines. These preliminary results suggest that CRN health plans did adopt aromatase inhibitors alongside the American Society of Clinical Oncology (ASCO) guidelines (published in 2004)41, but there are unknown barriers at these sites that prohibited more rapid adoption. The CRN presented a poster abstract of this work at the 2006 American Society of Preventive Oncology annual meeting, and was awarded first place for best poster presentation.

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Development of a shareable analytic dataset for studies of racial disparities Direct link to this project

Principal Investigator: Chyke Doubeni; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2005-10-01
Area(s) of Research: Health Disparities
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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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Comparing pancreatic cancer identification using health plan automated data & SEER cancer registry Direct link to this project

Principal Investigator: Reina Haque; KP Southern California
Funding Source: National Cancer Institute
Funding Start Date: 2005-10-01
Area(s) of Research: Epidemiology & Surveillance
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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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cancer Biomedical Informatics Grid (caBIG) Participation Contract (Pop Sci) Direct link to this project

Principal Investigator: Sarah Greene; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-03-07
Area(s) of Research: Informatics
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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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Cancer Prevention Index pilot study Direct link to this project

Principal Investigator: Thomas Vogt, MD, MPH, FAHA; KP Hawaii
Funding Source: National Cancer Institute
Funding Start Date: 2007-05-01
Area(s) of Research: Epidemiology & Surveillance; Health Services
Phases(s) of Care: Prevention
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This two-year pilot study 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 retrospectively

the variation in CPI scores across clinics and clinical practices, and determine the association of these variations to selected event rates several years later, to evaluate the association of clinician adherence to guidelines to 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. The study will explore how variations across practices in intervals between testing and percent of eligible persons tested relate to these outcomes, and will conduct preliminary analyses on the CPI primary prevention measures and their relation to outcomes. The pilot study will inform the development of an R01 that will assess the CPI measures in multiple health systems to relate practice-level variations in the scores of morbidity, mortality, and cost outcomes. A complementary CPI study that incorporates preventive practices relevant to cardiovascular disease was recently funded as part of the newly initiated Cardiovascular Research Network, sponsored by the National Heart, Lung, and Blood Institute.

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Diffusion of Ovarian Cancer Treatment Direct link to this project

Principal Investigator: Larissa Nekhlyudov; Harvard Pilgrim Health Care
Funding Source: National Cancer Institute
Funding Start Date: 2006-09-01
Area(s) of Research: Dissemination & Diffusion
Tumor Site(s): Ovary
Phases(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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DEcIDE Distributed-Data Network: Comparative Effectiveness and Safety of Second-line Anti-hypertensive Agents Direct link to this project

Principal Investigator: Rich Platt; Harvard Pilgrim Health Care
Funding Source: Agency for Healthcare Research and Quality
Funding Start Date: 2007-09-25
Area(s) of Research: Methods; Comparative Effectiveness
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The DEcIDE Network focuses primarily on comparative effectiveness of therapies to generate knew 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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Development of a method to assess obesity and treatment via EMR Direct link to this project

Principal Investigator: Brian Hazlehurst; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2005-10-01
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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Diffusion of breast MRI technology in community clinical settings Direct link to this project

Principal Investigator: Larissa Nekhlyudov; Harvard Pilgrim Health Care
Funding Source: National Cancer Institute
Funding Start Date: 2005-10-01
Area(s) of Research: Dissemination & Diffusion
Tumor Site(s): Breast
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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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Economic Burden pilot study Direct link to this project

Principal Investigator: Mark Hornbrook; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2007-06-22
Area(s) of Research: Economics; Health Services
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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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Effect of HIPAA Privacy Rule of Health Research Direct link to this project

Principal Investigator: Sarah Greene; Group Health
Funding Source: Institute of Medicine
Funding Start Date: 2006-11-01
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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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Is Stroke a Late Effect of Chemotherapy? Direct link to this project

Principal Investigator: Ann Geiger, MPH, PhD; Wake Forest University
Funding Source: National Cancer Institute
Funding Start Date: 2006-07-01
Area(s) of Research: Epidemiology & Surveillance; Outcomes
Tumor Site(s): Breast ; Colorectal ; Lymphoma ; Ovary ; Other
Phases(s) of Care: Survivorship
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This R01 grant, led by Dr. Ann Geiger of Wake Forest University, seeks to explore the hypothesis that chemotherapy may increase the risk of stroke for years after completion. The study team will estimate the relative risks of stroke due to chemotherapy among a group of over 30,000 ethnically diverse patients diagnosed from 1994 to 2003 with bladder, female breast, colorectal, Hodgkin’s lymphoma, adult leukemia, multiple myeloma,

non-Hodgkin’s lymphoma, and ovarian cancers, adjusting for age, gender, race/ethnicity, anatomic cancer site, stage at diagnosis, year of diagnosis, receipt of radiation

therapy, and dispensed medications for hypertension, diabetes, anticoagulants, and tamoxifen (for breast cancer only).

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

Principal Investigator: Christine Neslund-Dudas; Henry Ford Health System
Funding Source: Department of Defense
Funding Start Date: 2007-04-01
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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Multiplex Genetic Susceptibility Testing: An Interdisciplinary Collaboration Direct link to this project

Principal Investigator: Eric Larson; Group Health
Funding Source: National Human Genome Research Institute
Funding Start Date: 2006-03-01
Area(s) of Research: Health Literacy; Behavior
Phases(s) of Care: Screening; Prevention
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There are two primary objectives of the Multiplex Initiative. The first objective is to explore how individuals respond to being offered the Multiplex Genetic Test for complex common diseases and how they respond to receiving their test results. The specific research aims are to learn:

Who will be most interested in and want Multiplex Genetic Testing? (Baseline Assessment Cohort)

Whether individuals who are tested will be able to accurately interpret their test results and how will this interpretation be associated with the occurrence of positive and negative affect, risk perceptions, and other indicators of information processing (e.g., time spent reviewing the information and evaluation of the quality and credibility of the information)? (Tested Cohort), and

How test results, perceptions about test results, and other psychosocial variables will influence information seeking behavior? (Tested Cohort)

The second objective is to build an infrastructure through which future research participants can be offered the Multiplex Genetic Test protocol, and multiple ancillary trans-disciplinary research studies can then be built around this infrastructure to answer social and behavioral research questions.

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

Principal Investigator: Laurie Habel; KP Northern California
Funding Source: National Cancer Institute
Funding Start Date: 2005-09-01
Area(s) of Research: Biology & Etiology; Epidemiology & Surveillance; Genetics
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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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Outcomes of genetic counseling for heritable breast/ovarian cancer: Feasibility of identifying cohort through EMR Direct link to this project

Principal Investigator: Brian Hazlehurst; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2005-10-01
Area(s) of Research: Epidemiology & Surveillance; Methods
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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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Quality of Patient-centered cancer care, communication and coordination Direct link to this project

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2005-01-01
Area(s) of Research: Health Services; Quality of Care
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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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Increasing Technology to Maximize Use of the VDW at all CRN Sites Direct link to this project

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2005-10-01
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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Socioeconomic Diversity in Integrated Healthcare Delivery Systems Direct link to this project

Principal Investigator: Chyke Doubeni; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
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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Chemotherapy and Coinsurance: The Effect of Cost Sharing on Cancer Care Direct link to this project

Principal Investigator: Debra Ritzwoller, PhD; KP Colorado
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
Area(s) of Research: Economics; Health Services; Policy
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Background

This project complements and builds on several components of the Cancer Research Network (CRN) infrastucture, including the Virtual Data Warehouse (VDW). This pilot study is designed to begin to address the following questions: Does the implementation of injectable/infusion coinsurance adversely affect receipt of first-choice cancer chemotherapy services? Does the level of out-of-pocket-maximum payement for these services, or socioeconomic circumstances adversely affect receipt of recommended chemotherapy services in vulnerable subgroups of patients with major comorbidities, or those in low income areas? This is a multi-year, multi-site (initially KPCO & Kaiser Permanente Georgia (KPGA)), retrospective, observational study of 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 two sites.

Specific aims

  1. Construct a set of time series for the period 2006-2008 with month-by-month measurement of the proportion breast, colorectal, and lung cancer patients who receive first-choice cancer chemotherapy services – as defined by American Society of Clinical Oncologist (ASCO)-derived guidelines, which are currently employed by all Kaiser regions.
  2. Use time-series regression methods to test the overall hypothesis that patients facing the implementation of the coinsurance will be less likely, over time, to receive the same level chemotherapy services (adjusting for age, gender, stage, geocoded proxy measures of SES, etc).

Significance

We hypothesize that a smaller percentage of patients will choose to pursue first-choice chemotherapy as a result of cost sharing measures. This work will provide the pilot data needed to move forward with a larger multi-site study (R01 or ACS application) that could include multiple CRN sites, and could address a larger set of questions related to patient and provider decision making, outcomes, and costs. In addition, this study will leverage the ongoing efforts of the CRN VDW Chemotherapy working group. With the 2008 implementation of a 20% coinsurance that applies to office-administered injectables/infusions at one CRN site, this is an unparalleled opportunity for the CRN to help inform policy makers 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, it is essential for us to begin to understand how these changes may impact cancer treatment, compliance, outcomes, and costs.

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

Principal Investigator: Carol Somkin; KP Northern California
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
Area(s) of Research: Epidemiology & Surveillance; Health Services
Tumor Site(s): Colorectal
Phases(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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Media Coverage and Direct-to-Consumer Advertising of Genetic Tests Direct link to this project

Principal Investigator: Alanna Rahm; KP Colorado
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
Area(s) of Research: Genetics; Health Services
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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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cancer Biomedical Informatics Grid (caBIG) Participation Contract (DSIC) Direct link to this project

Principal Investigator: Sarah Greene; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-03-07
Area(s) of Research: Informatics
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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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Intestinal ostomies and informal caregiving for colorectal cancer survivors Direct link to this project

Principal Investigator: Carmit McMullen; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2009-04-01
Area(s) of Research: Psychosocial/Quality of Life
Tumor Site(s): Colorectal
Phases(s) of Care: Survivorship
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Background

In the US today, over one million people are living with intestinal ostomies, most of whom are colorectal cancer (CRC) survivors. A colostomy or ileosotomy is a physical impairment that leads to bowel incontinence unless it is properly managed on a daily basis with special equipment, diet, and behavior.

Losing the ability to manage one’s ostomy independently -- whether due to acute illness, co-morbidities, or functional declines -- can transform an ostomy from a manageable impairment to a source of profound disempowerment, stigma, and disability. Our proposed ethnography will use a social model of disability framework to better understand the interrelationships among disability and caregiving in this population. Bowel management is a highly personal and potentially stigmatizing issue, and daily ostomy management involves regulation and routines around diet, ostomy equipment maintenance, and elimination. Therefore, our central hypothesis is that having an ostomy profoundly impacts experiences of disability and aspects of caregiving, and that these impacts will be especially acute during changes in ostomates’ functional status and transitions in their caregiving situations. Our study continues a long-standing research program on the quality of life of long-term colorectal cancer survivors.

Specific Aims

This study’s specific aims are to examine the caregiving challenges and coping strategies of longterm CRC survivors with intestinal stomas (at least 5 years since diagnosis) and their informal caregivers (e.g., spouse or relative) (N=30 dyads). We will conduct in-depth interviews and observe participants to discover the following: 1) how an intestinal ostomy affects experiences of disability and caregiving; 2) key transitions and challenges in disability and caregiving experiences; and 3) strategies that ostomates and their caregivers employ to cope with caregiving challenges.

Significance

This study addresses the understudied topic of caregiving for long-term cancer survivors and, in particular, the functional challenges of aging with an ostomy. We will provide critical information that will help design effective and desired ways to improve the function and quality of life of patients and their families. Finally, this study is based in a non-referral managed care population that is generalizable to communities across the US.

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Multicenter Study of Pancreatic Cancer Etiology Direct link to this project

Principal Investigator: Meg Mandelson, PhD; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2004-07-15
Area(s) of Research: Epidemiology & Surveillance
Tumor Site(s): Pancreas
Phases(s) of Care: Diagnosis
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The Pancreatic Cancer Investigation: Finding Causes (PACIFIC) study is a large case-control study with recruitment based in two CRN HMOs (GHC and KPNC) with infrastructure to support ultra-rapid case identification as patients move through diagnostic evaluation. Led by Dr. Margaret Mandelson of GHC and by Dr. Stephen Van Den Eeden of Kaiser Permanente Northern California, this study’s methods allow researchers to enroll patients who represent the full spectrum of disease,including those typically omitted from prior epidemiologic research because of death shortly following diagnosis. Data collection consists of interview, biospecimen collection, and medical record review. With an anticipated recruitment of approximately 1,500 cases and controls, this is one of the largest and most comprehensive epidemiologic studies of pancreatic cancer undertaken to date.

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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

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-09-01
Area(s) of Research: Epidemiology & Surveillance; Health Services; Methods
Tumor Site(s): Breast
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This CRN proposal represents the collaborative efforts of four multi-center 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 Special Interest Group of the HMORN, and the CRN. These networks contribute to, and use, a common data infrastructure. The primary goal of this project is to create a population research laboratory to conduct pharmacoepidemiologic and pharmacogenomic studies. The project will use a highly developed research infrastructure and multi-disciplinary team within the CRN and will draw on other expertise within the HMORN to demonstrate our capability of efficiently performing high quality population-based pharmaco-epidemiologic and pharmacogenomics studies. A second goal is to use this laboratory to examine important questions about the cardiotoxicity of systemic agents used to treat invasive breast cancer. The remainder of this proposal will distinguish the aims and activities associated with these two goals.

1. Infrastructure Development

a. To assess the validity of electronic data on chemotherapy infusion.

b. To adapt and test alternative strategies for identifying cardiotoxicity (e.g., congestive heart failure, cardiomyopathy, reduction in left ventricular ejection fraction (LVEF)) using the Virtual Data Warehouse (VDW) data or other electronic data.

c. To explore the feasibility of strategies for assembling biological specimens and collecting DNA samples on study subjects.

d. To add analytic variables for chemotherapy dose, route, and type and cardio-toxicity outcomes data to the VDW among all HMORN sites using validated algorithms developed from specific aims 1a and 1b.

2. Cardiotoxicity Study

a. To identify a cohort of patients with incident invasive breast cancer, and use the VDW and other electronic data sources to determine outcomes for each member of the cohort.

b.To estimate the risk of cardiotoxicity associated with herceptin, anthracycline, joint herceptin and anthracycline, and other chemotherapy regimens including their sequence and timing of therapy and cumulative doses adjusted for demographic characteristics, presence of co-morbidity and other factors.

Relevance

The project will use a highly developed research infrastructure to demonstrate our capability of efficiently performing high quality population-based pharmacoepidemiologic and pharmacogenomics studies. Although randomized clinical trials provide crucial safety and efficacy data regarding cancer treatments, these studies generally include design features that may limit their usefulness in assessing the effectiveness and safety of cancer diagnostic and treatment modalities in practice.

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

Principal Investigator: Chyke Doubeni; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2007-09-01
Area(s) of Research: Health Disparities
Tumor Site(s): Colorectal
Phases(s) of Care: Screening; Diagnosis; Treatment
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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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CRN Clinical Communication Research Center Direct link to this project

Principal Investigator: James Dearing; KP Colorado
Funding Source: National Cancer Institute
Funding Start Date: 2008-09-30
Area(s) of Research: Communication; Quality of Care
Tumor Site(s): All
Phases(s) of Care: Diagnosis; End of Life; Prevention; Screening; Survivorship; Treatment
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Objectives

The long-term objective of establishing the CRN Clinical Communication Research Center is to identify and test optimal communication and coordination processes that facilitate patient-centered cancer care in clinical settings. We will pursue this goal across the cancer care continuum – from prevention to early detection, diagnosis, treatment, survivorship, to end of life – and across types – from breast, cervical, colorectal, lung, prostate, and other cancers. We propose an internally consistent research and practice agenda focused on clinical applications and pair these inquiries with established expertise in communication, dissemination, and implementation scholarship that models the cutting-edge realities of organized healthcare.

Specific aims

  1. To leverage an existing administrative and scientific infrastructure (the Cancer Research Network, with over 10 million enrollees, comprising 14 integrated healthcare delivery systems across the United States) to support the synergies of discovery and dissemination of practice-based communication strategies and organizational resources for improving patient experiences across the cancer care continuum
  2. To support three investigator-initiated research projects to advance communication theory and to evaluate efficacy of practice-based communication strategies informed by theory
  3. Provide administrative and scientific support to new investigators, including clinicians, in development of pilot projects, financial assistance to meritorious projects, and assist in submission of broader, investigator-initiated proposals to be submitted for extramural funding
  4. Engage doctoral students, post-doctoral researchers, and healthcare clinicians and researchers in learning about clinical applications of patient-centered cancer communication.

Methods

The Center’s research projects will be augmented by Shared Resource Cores that will work to identify effective innovations in patient-centered cancer communication and healthcare team coordination, and effectively disseminate and implement evidence-based cancer communication practices to healthcare systems across the nation.

Significance

Public health will be improved through the creation and operation of the CRN Clinical Communication Research Center because the unique and diverse Cancer Research Network already exists as a test-bed. We will extend its purpose to the study of patient-centered communication. High quality communication with patients produces better public health outcomes.

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

Principal Investigator: Kathleen Mazor; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
Area(s) of Research: Communication; Behavior
Phases(s) of Care: Prevention
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This study proposes to develop a test to assess comprehension of oral (i.e., spoken)messages about cancer prevention and screening, to examine the relationship between health literacy and cancer prevention, and to test whether changing oral messages can improve comprehension. 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; identification of risk factors and causes of limited comprehension; and development and evaluation of interventions to improve comprehension of orally transmitted messages. The study team will use both quantitative and qualitative methods to identify the factors that affect comprehensibility of oral

messages about cancer prevention and screening. 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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Increasing Patient Participation in Clinical Trials Direct link to this project

Principal Investigator: Carol Somkin; KP Northern California
Funding Source: National Cancer Institute
Funding Start Date: 2007-05-01
Area(s) of Research: Health Services
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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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Infrastructure: Cancer Research Network Across Health Care Systems Direct link to this project

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-05-01
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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Medical care burden of cancer: system and data issues Direct link to this project

Principal Investigator: Mark Hornbrook; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2007-08-01
Area(s) of Research: Economics; Health Services
Tumor Site(s): All
Phases(s) of Care: Treatment
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Background

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.

Specific aims

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:

  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.
  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.
  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.

Significance

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

Principal Investigator: Rebecca Silliman, MD, PhD; Boston University Medical Center
Funding Source: National Cancer Institute
Funding Start Date: 2008-09-10
Area(s) of Research: Epidemiology & Surveillance; Health Disparities; Quality of Care
Tumor Site(s): Breast
Phases(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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Race, Treatment and Cardiovascular Health: A Study of Men with Prostate Cancer Direct link to this project

Principal Investigator: Andrea Cassidy, PhD, MPH; Henry Ford Health System
Funding Source: Department of Defense
Funding Start Date: 2009-04-01
Area(s) of Research: Health Disparities
Tumor Site(s): Prostate
Phases(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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Medical Radiation Induced Cancers Direct link to this project

Principal Investigator: Diana Miglioretti, PhD; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2009-05-01
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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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Development of a Model for Predicting Prostate Cancer Direct link to this project

Principal Investigator: Deanna Cross, PhD; Marshfield Clinic Research Foundation
Funding Source: National Cancer Institute
Funding Start Date: 2009-05-01
Tumor Site(s): Prostate
Phases(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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Preventing Errors in the Home Care of Children with Cancer Direct link to this project

Principal Investigator: Kathleen Walsh, MD, MSc; University of Massachusetts
Funding Source: National Cancer Institute
Funding Start Date: 2009-05-01
Phases(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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Childhood, Adolescent and Young Adult Cancer Survivors - CRN Feasibility Pilot Direct link to this project

Principal Investigator: Sarah Greene; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2009-05-01
Area(s) of Research: Outcomes
Phases(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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Effective Communication for Preventing and Responding to Oncology Adverse Events Direct link to this project

Principal Investigator: Sarah Greene; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-09-30
Area(s) of Research: Communication
Tumor Site(s): All
Phases(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

Principal Investigator: Ed Wagner; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2008-09-30
Area(s) of Research: Quality of Care
Phases(s) of Care: Diagnosis; Treatment
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Major Goals

To assess the impact of a nurse intervention for cancer patients that provides information and decision-making support, self-management and psychosocial support, and care coordination to cancer patients from diagnosis to the end of primary therapy on the experience and timeliness of care, self-efficacy and self-management, emotional distress, physical symptoms, treatment adherence, and quality of life. The intervention will be implemented and evaluated in three different delivery models.

Specific Aims

  1. To develop a robust early cancer notification based on automated extraction of Pathology reports to facilitate contact of patients shortly after diagnosis.
  2. To develop a patient assessment tool for patients newly diagnosed with cancer that includes information needs, learning style and decision-making preferences, psychosocial distress and needs, depressive and anxiety symptoms, physical symptoms, patient activation and self-efficacy, quality of life, and quality of healthcare.
  3. To develop nurse counseling and referral interventions to respond to problems identified on the assessment and to facilitate timely, coordinated care.
  4. To compare the impact of the nurse intervention on psychosocial distress and symptoms of anxiety and depression, physical symptoms, quality of life, and satisfaction with the quality, timeliness, and patient-centeredness of their care with enhanced usual care on Group Health cancer patients using a randomized clinical trial design.
  5. To compare the impacts of the nurse intervention on outcomes in three different Group Health (GHC) delivery models – GHC primary care and specialty services; GHC primary care and outside specialty services; and network primary care and specialty services.
  6. To develop conceptual and analytic models of how each component of the nurse intervention could impact intermediate and final outcomes in an effort to determine the magnitude and pathway(s) of any noted effects.

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

Principal Investigator: Diana Buist; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-30
Area(s) of Research: Epidemiology & Surveillance; Comparative Effectiveness
Tumor Site(s): Cervical ; Colorectal
Phases(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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Comparative Effectiveness Research in Genomic & Personalized Medicine of Colorectal Cancer Direct link to this project

Principal Investigator: Katrina Goddard, PhD; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-30
Area(s) of Research: Genetics; Comparative Effectiveness
Tumor Site(s): Colorectal
Phases(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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Building CER Capacity: Aligning CRN, CMS and State Resources to Map Cancer Care Direct link to this project

Principal Investigator: Jane Weeks; Dana Farber Cancer Institute
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-30
Area(s) of Research: Comparative Effectiveness
Phases(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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Improving breast cancer surgery effectiveness through establishment of an electronic cancer surgery database Direct link to this project

Principal Investigator: Larry McCahill, MD; Van Andel Research Institute
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-30
Area(s) of Research: Quality of Care; Comparative Effectiveness
Tumor Site(s): Breast
Phases(s) of Care: Treatment
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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

Principal Investigator: David Carrell, PhD; Group Health
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-30
Area(s) of Research: Epidemiology & Surveillance; Informatics
Tumor Site(s): Breast
Phases(s) of Care: Diagnosis; Screening; 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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Cost-Effectiveness of Hormonal Therapy for Clinically Localized Prostate Cancer Direct link to this project

Principal Investigator: Stephen K. Van Den Eeden; KP Northern California
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-30
Area(s) of Research: Comparative Effectiveness
Tumor Site(s): Prostate
Phases(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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Medical Care Burden of Cancer: System and Data Issues: Supplement Direct link to this project

Principal Investigator: Mark Hornbrook; KP Northwest
Funding Source: National Cancer Institute
Funding Start Date: 2009-08-01
Area(s) of Research: Economics
Phases(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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Understanding Racial and Ethnic Differences in Survival from Colorectal Cancer supplement Direct link to this project

Principal Investigator: Chyke Doubeni; Meyers Primary Care Institute
Funding Source: National Cancer Institute
Funding Start Date: 2009-09-25
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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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