Quality of Life End Points in Cancer Clinical Trials: Review and Recommendations

Abstract

In this presentation, issues that influenced the developmentof policies for inclusion of quality of life end points in cer-tain Southwest Oncology Group clinical trials are reviewed. The key policies recommended by us and adopted by the Cancer Control Research Committee of the Southwest On-cology Group are as follows: (a) Begin assessment of qualityof life in specific types of phase III protocols, (b) Alwaysmeasure physical functioning, emotional functioning, symp-toms (general and protocol specific), and global quality oflife separately, (c) Include measures of social functioningand additional protocol-specific measures if resources per-mit, (d) Use patient-based questionnaires with psychometric properties that have been documented in published studies. In this review, we also recommend specific questionnaires. Our recommendations may prove useful for other cancerclinical trials groups and for multi-institution trials of treat-ment for chronic diseases. [J Natl Cancer Inst 81:485-495,1989]