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Quality-of-Life Assessment in the Symptom Management Trials of the National Cancer Institute-Supported Community Clinical Oncology Program

From the Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD

Address reprint requests to David Buchanan, DrPH, Division of Cancer Prevention, National Cancer Institute, 6130 Executive Blvd, Room EPN 2149, Bethesda, MD, 20892-7317; e-mail: buchanad{at}mail.nih.gov

PURPOSE: To examine how quality of life (QOL) is prospectively conceptualized, defined, and measured in the symptom management clinical trials supported by the National Cancer Institute Community Clinical Oncology Program (CCOP).

METHODS: All QOL research objectives, rationales, assessment instruments, symptoms treated, and types of interventions from the CCOP symptom management portfolio of clinical trials were extracted and analyzed.

RESULTS: QOL assessments were proposed in 68 (52%) of the 130 total CCOP symptom management trials initiated since 1987. A total of 22 global QOL instruments were identified. Both the frequency of symptom management trials and the frequency of QOL assessment have increased significantly over time. The Functional Assessment of Cancer Therapy and Uniscale instruments were the most widely used QOL instruments, included in 55% of trials assessing QOL. The conceptual framework for QOL inclusion was limited to univariate relationships between symptom relief and global improvements in QOL. No consistent associations were found between QOL assessment and either the symptoms targeted or types of interventions.

CONCLUSION: To advance the state of the science, research protocols need to provide more explicit rationales for assessing QOL in symptom management trials and for the selection of the QOL instrument(s) to be used. Conceptual frameworks that specify the hypothesized links between the specific symptom(s) being managed, interactions with other symptoms, different domains of QOL, and global QOL also need to be more precisely described. Methodologic and conceptual advances in QOL symptom management trials are critical to fulfill the promise of alleviating suffering and improving the QOL of cancer patients.

Supported by the Cancer Prevention Research Fellowship program at the National Cancer Institute, Bethesda, MD.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 30-June 3, 2003 and at the 10th Annual Meeting of the International Society for Research on Quality of Life, Prague, Czech Republic, November 12-15, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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