Carol McMillen Moinpour

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