Carol M. Moinpour
Ph.D., University of Washington, Psychology, 1973.
M.A., Ohio State University, Psychology, 1965.
B.S., Ohio State University, Education, 1963.
BEHAVIORAL SCIENCE IN CANCER CLINICAL TRIALS RESEARCH: QUALITY OF LIFE OUTCOMES:
The Southwest Oncology Group is a cancer clinical trials organization funded by the National Cancer Institute to evaluate new treatments for cancer and to identify ways to prevent cancer. As a psychologist at the Southwest Oncology Group's Statistical Center (located at the Fred Hutchinson Cancer Research Center), I help coordinate quality of life and behavioral research conducted in SWOG trials.
A number of outcomes or endpoints are used to evaluate the effectiveness of a new cancer treatment (e.g., overall survival time, decrease in tumor size, etc.). Comprehensive and systematic reports from patients of their quality of life during and after cancer treatment can also help evaluate cancer treatments. A comprehensive measure of quality of life involves a patient-completed questionnaire or interview addressing physical, emotional, and social functioning as well as symptom status and a global assessment of quality of life. It is important to include questions about symptoms that are associated with the cancer (e.g., bone pain) as well as symptoms associated with the treatment (e.g., nausea or mouth sores). Systematic assessment requires collecting information from patients on a regular schedule and in a standardized fashion. These data can supplement physicians' inquiries regarding how patients are doing and the physician ratings of patient symptoms (treatment-related toxicities) routinely collected in clinical trials.
A difficult issue in quality of life research is deciding when and for how long patients should rate their functioning. Sometimes, we are interested in documenting the side effects associated with a treatment (i.e., more short-term, acute effects). In other cases, we are more interested in seeing if quality of life improves over time and documenting the degree to which patients are able to return to normal work and family routines. Or, we may want to follow patients long enough to be certain that there are no long-term negative effects of the cancer treatment. Quality of life issues in some studies are more compelling than in others. For example, treatment for patients with advanced stage disease is usually expected to be palliative rather than curative. A quality of life questionnaire is an excellent way of documenting the extent to which palliation was achieved. Finally, quality of life outcomes are also of interest in cancer prevention trials. In this case, the objective is monitoring the continued health status and quality of life of healthy individuals who enroll in a cancer prevention study.
In Southwest Oncology Group clinical trials. We have documented both symptom reduction over the course of treatment and increases in symptoms as a result of treatment-related side effects. We have also shown that baseline measures of symptom status and physical functioning predict patient survival. With funding from the National Cancer Institute, we have translated the SWOG Quality of Life Questionnaire into Spanish and are conducting a study to validate the translation. We are currently assessing the quality of life of healthy men participating in the Prostate Cancer Prevention Trial (PCPT). We will also be monitoring quality of life in a newly funded prostate cancer prevention trial, the SELenium and Vitamin E Chemoprevtion Trial (SELECT). My work on the PCPT includes efforts to encourage recruitment to the trial, particularly among members of minority groups. A minority recruitment manual was produced for the PCPT. Additional effort and research targeted adherence to PCPT trial requirements over its seven-year period and involved focus groups, production of videos, and activities conducted by sites to encourage adherence. My work on the SELECT trial addressed early recruitment activities. I have designed the quality of life assessment strategy for both the PCPT and SELECT trials in conjunction with a number of colleagues who do research in this area. Finally, quality of life questionnaires provide the primary outcomes for evaluating the effectiveness of a counseling intervention for women with a first recurrence of breast cancer.
Cost is another relevant outcome measure for cancer clinical trials. I have helped develop a set of resource utilization forms to document cost of care for two treatment arms in an advanced non-small cell lung cancer trial conducted by the Southwest Oncology Group. This type of outcome is very staff-intensive and will only be included in selected trials. However, cost information certainly adds to the evaluation of competing treatments for cancer. We have also been able to document the resource-intensive nature of collecting and monitoring submission of quality of life data in Southwest Oncology Group trials, particularly at the data center.
I am working with colleagues in the Clinical Division who are monitoring the quality of life of patients who received bone marrow transplants at the Fred Hutchinson Cancer Research Center and have now returned home. I am also working with colleagues in the Cancer Prevention Research Program and, if funded, we will conduct a set of five interventions to address the needs of patients with breast cancer and their fa
International Society for Quality of Life Research
Southwest Oncology Group
1999-2008, Associate Member, Fred Hutchinson Cancer Research Center, Biostatistics Program/Southwest Oncology Group, Divison of Public Health Sciences
ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation.. 2013.
Patient income level and cancer clinical trial participation.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 31(5):536-42.. 2013.
Intermittent versus continuous androgen deprivation in prostate cancer.. The New England journal of medicine. 368(14):1314-25.. 2013.
Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monothe. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 21(5):765-775.. 2012.
Evaluating health-related quality-of-life therapeutic effectiveness in a clinical trial with extensive nonignorable missing data and heterogeneous response: results from a phase III randomized trial of gemcitabine plus paclitaxel versus paclitaxel monothe. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 21(5):765-75.. 2012.
Willingness to Pay for Prostate Cancer Treatment among Patients and Their Family Members at 1 Year After Diagnosis.. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 15(5):716-23.. 2012.
Provider and partner interactions in the treatment decision-making process for newly diagnosed localized prostate cancer.. BJU international. 108(6):851-6.. 2011.
Patient preferences and urologist recommendations among local-stage prostate cancer patients who present for initial consultation and second opinions.. World journal of urology. 29(1):3-9.. 2011.
Considering racial and ethnic preferences in communication and interactions among the patient, family member, and physician following diagnosis of localized prostate cancer: study of a US population.. International journal of general medicine. 4:481-6.. 2011.
Preliminary treatment considerations among men with newly diagnosed prostate cancer.. The American journal of managed care. 16(5):e121-30.. 2010.
Pain and emotional well-being outcomes in Southwest Oncology Group-directed intergroup trial S0205: a phase III study comparing gemcitabine plus cetuximab versus gemcitabine as first-line therapy in patients with advanced pancreas cancer.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 28(22):3611-6.. 2010.
Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial.. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 18(2):147-55.. 2009.
Mediators, moderators, and modulators of causal effects in clinical trials--Dynamically Modified Outcomes (DYNAMO) in health-related quality of life.. Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation. 18(2):137-45.. 2009.
Late cardiac effects of adjuvant chemotherapy in breast cancer survivors treated on Southwest Oncology Group protocol s8897.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 26(8):1223-30.. 2008.
Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 26(1):112-20.. 2008.
Phase III randomized placebo-controlled trial of two doses of megestrol acetate as treatment for menopausal symptoms in women with breast cancer: Southwest Oncology Group Study 9626.. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 26(10):1650-6.. 2008.