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Journal of Clinical Oncology, Vol 22, No 15 (August 1), 2004: pp. 2992-2996 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.06.020
Understanding Cancer Treatment and Outcomes: The Cancer Care Outcomes Research and Surveillance Consortium
1 Division of General Medicine, Department of Medicine, Brigham and Women's Hospital, Department of Health Care Policy, Harvard Medical School, Boston, MA Cancer treatments and outcomes are less than optimal for many patients in the United States.1,2 To understand the reasons for such variations in care, the National Cancer Institute (NCI) has funded the Cancer Care Outcomes Research and Surveillance (CanCORS) Consortium. This consortium is a centerpiece of the NCI's ongoing initiative to improve cancer care.3,4 The purpose of this commentary is to introduce the goals and methods of the CanCORS Consortium to the broader community of cancer researchers and clinicians, many of whom are caring for patients participating in this study. The CanCORS Consortium is conducting a rigorous observational study to identify clinically important differences in cancer treatment and outcomes and evaluate the reasons for these differences across a wide range of patients, health care providers, and organizations.5 This approach is designed to complement randomized clinical trials of specific treatments that are typically conducted among highly selected patients and providers.6 Prior observational studies have also assessed selected groups of patients or used databases with limited clinical information. In contrast, the CanCORS Consortium will collect much more detailed data from patients, physicians, and medical records to support more comprehensive analyses of the reasons for variations in treatment and outcomes. The consortium has two principal research aims. The first aim is to determine how the characteristics and beliefs of cancer patients and providers and the characteristics of health care organizations influence treatments and outcomes, spanning the continuum of cancer care from diagnosis to recovery or death. This research is not designed to develop measures of quality of care per se, but it will help to guide the use of such measures in the future.7 The second aim is to evaluate the effects of specific therapies on patients' survival, quality of life, and satisfaction with care, supplementing rather than substituting for data from randomized clinical trials. Organized in 2001 through a cooperative agreement with independent investigators across the country,8 the consortium's mission is to evaluate the care of newly diagnosed patients with lung or colorectal cancer in multiple regions and health care delivery systems. This collaboration represents a new model for studying cancer care: a large, distributed, multidisciplinary team of investigators collecting shared data. This approach enables the consortium to address a broader array of important clinical and policy questions than would typically be feasible at a single site: Why are there racial, ethnic, and socioeconomic differences in cancer care and outcomes?9-11 Why do older patients receive less intensive treatment for cancer?12-16 How do patients and physicians make decisions about therapies for metastatic cancer?17 Why do cancer outcomes vary by case volume?18-21 Why is participation in clinical trials so low for lung and colorectal cancer? Are patients' symptoms recognized and treated effectively? What is the effectiveness of therapies such as adjuvant chemotherapy for stage III colon cancer and first-line chemotherapy for metastatic lung or colorectal cancer among patients in the community who have generally not been included in clinical trials, including older patients or those with substantial comorbidity?6 The consortium is composed of six research groups funded by the NCI and one research group funded by the Department of Veterans Affairs (Table 1). The seven groups include five geographically defined regions, five integrated health care delivery systems in the NCI-funded Cancer Research Network, and 10 Veterans hospitals (Fig 1). These study sites have a total population of 29.6 million people. During the year 2000, more than 15,000 people were diagnosed with lung cancer and more than12,000 people were diagnosed with colorectal cancer in these sites.
Enrollment of patients in the CanCORS study began in September 2003 and will continue for approximately 18 months. Patients 21 years of age and older with newly diagnosed invasive non–small-cell or small-cell lung cancer or adenocarcinoma of the colon or rectum are eligible and are being identified within 3 months of diagnosis.22 Across all sites, approximately 5,000 patients with lung cancer and 5,000 patients with colorectal cancer will be enrolled. Several sites are oversampling African American, Hispanic, and Asian or Pacific Islander patients, so an estimated 64% of the study cohort will be white, 20% African American, 8% Hispanic, and 8% Asian or Pacific Islander. Three types of primary data are being collected for the CanCORS study: patient surveys, physician surveys, and data from medical records. The patient survey (available on request at http://www.cancors.org/public) has been designed to assess a broad range of topics for which patients are typically the best source of information, including their decision making about major treatments, symptoms of pain and depression, assessments of their care, and financial burdens related to treatment. Many items and scales have been obtained from prior published surveys, such as questions about patients' symptoms and quality of life.23-25 To enhance the diversity of the cohort, telephone interviews are being conducted in English, Spanish, and Mandarin and Cantonese Chinese. For patients who are too ill to complete the survey and those who have died, an interview with a family member or another surrogate who is familiar with the patients' condition and treatment is being conducted. To understand how physicians' beliefs and characteristics influence the processes of care and outcomes of patients in the CanCORS study, physicians who made referrals for cancer care, treated cancer-related symptoms, or were involved in decisions about treatment are being surveyed. This survey focuses on physicians' beliefs about the effectiveness of treatments for lung or colorectal cancer in various clinical scenarios, but does not ask questions about the treatment of specific CanCORS patients. Data from the physician survey will be linked with information from the patient survey and medical records to explain observed variations in treatment and outcomes. Important data to be obtained from medical records include cancer-related diagnostic procedures, staging procedures, surgery, chemotherapy, and radiation therapy. Special effort is being devoted to identify reasons that potentially appropriate treatments were not provided to patients. Key predictors of clinical outcomes are also being collected, including tumor stage, comorbid illnesses,26-28 and relevant test results.29-31 After obtaining patients' consent to review medical records, research staff will contact hospitals and physicians to request photocopies of medical records or review these records on-site at hospitals and physicians' offices. Practicing physicians who care for patients with lung cancer or colorectal cancer in the CanCORS study will have numerous opportunities to contribute to the success of this important research endeavor. Physicians can encourage their patients to consider participating, facilitate contact with surrogate respondents for patients who have died, and provide research staff with reasonable access to office records for patients who have given written consent to release these data. Many physicians will also be invited to share their views on cancer treatment through the confidential physician survey. High rates of participation by eligible patients and physicians are essential to enroll representative cohorts and obtain high-quality data. The CanCORS study has three major strengths that together distinguish it from prior studies of cancer care. First, diverse cohorts with each type of cancer are being prospectively enrolled from multiple regions and health care systems. Second, patients are being surveyed relatively soon after diagnosis, so that their beliefs, symptoms, and health care experiences can be assessed in a timely manner. Third, by blending extensive surveys of patients and physicians with detailed clinical data from medical records, the study has unparalleled breadth and depth. The consortium also faces several major challenges. Patients with more advanced cancer may be difficult to interview because of the rapid progression of their disease, so special efforts are being made to recruit and interview these patients or their surrogates. To facilitate access to medical records under new federal privacy regulations recently implemented under the Health Insurance Portability and Accountability Act,32 all procedures for data collection are compliant with these regulations. An important analytic challenge is to account for potential selection biases and confounding that may influence patients' treatment choices and outcomes. With detailed clinical and demographic data, rigorous statistical methods, such as propensity scores or instrumental variables, will be used to meet this challenge.33,34 The CanCORS Consortium is one of the most comprehensive observational studies ever undertaken to understand the experiences, treatments, and outcomes of patients with lung cancer or colorectal cancer in the United States. Several other studies of cancer care have demonstrated the feasibility of the consortium's research methods, including detailed surveys of patients and physicians and reviews of medical records.10,16,35-38 Building on these prior studies, the consortium will inform ongoing efforts to develop data systems for monitoring the quality of cancer care, investigating disparities in treatments and outcomes, and identifying opportunities to improve patients' experiences with cancer.39 With the active participation of patients and their physicians, the CanCORS Consortium represents an unprecedented opportunity to understand cancer care in the United States more fully, thereby providing crucial insights to clinicians and policy-makers for improving the care of patients with cancer. Note: This study is supported by grants from the National Cancer Institute (U01 CA93324, U01 CA93326, U01 CA93329, U01 CA93332, U01 CA93339, U01 CA93344, and U01 CA93348) and the Department of Veterans Affairs (CRS 02-164). Authors' Disclosures of Potential Conflicts of Interest The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Acted as a consultant within the past 2 years: Katherine L. Kahn, American Society of Clinical Oncology; Jennifer L. Malin, PacificCare Prescription Solutions, Intelligent Healthcare; Dawn T. Provenzale, Council of Healthcare Advisors; Robert S. Sandler, GlaxoSmithKline, Takeda, TAP, Novartis, Procter & Gamble, Merck. Performed contract work within the past 2 years: Elizabeth A. Chrischilles, Amgen, Inc; Robert S. Sandler, Merck. Received more than $2,000 per year from a company for either of the past 2 years: Elizabeth A. Chrischilles, Amgen, Inc; Robert S. Sandler, GlaxoSmithKline, Takeda, TAP, Novartis, Procter & Gamble, Merck.
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36. Potosky AL, Harlan LC, Stanford JL, et al: Prostate cancer practice patterns and quality of life: The Prostate Cancer Outcomes Study. J Natl Cancer Inst 91:1719-1724, 1999 37. Weeks JC: Outcomes assessment in the NCCN: 1998 update. Oncology 13:69-71, 1999 38. RAND/UCLA: Los Angeles Women's Health Care Study. http://www.rand.org/health/lawhcs 39. Hewitt M, Simone JV: Enhancing Data Systems to Improve the Quality of Cancer Care. Washington, DC, National Academy Press, 2000
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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), and Veterans Health Administration hospitals (
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