January 10, 2011

Measuring Quality of Life in Cancer Trials

(Ivanhoe Newswire) -- Quality of life measures seem to be most useful for clinical decision-making in trials where quality of life is the primary outcome, according to a new study.

There has been increasing interest in the value of patient-reported symptom assessments and their potential usage as primary or secondary endpoints in new trials.

Both the World Health Organization and the U.S. Food and Drug Administration have endorsed quality of life measures, but they are not always incorporated into trials because of the additional resources needed for data collection. However, quality of life measures remain important for women who have completed therapy. Many have symptoms such as fatigue, cognitive complaints, sleep and sexual problems, and neuropathy. At the other end of the spectrum, for advanced breast cancer patients on palliative treatments with toxicities, it would be important to determine if any observed survival benefit is outweighed by that burden.

To determine how quality of life measures are used in clinical trials, Julie Lemieux, M.D., of the Universit© Laval in Qu©bec, Canada, and colleagues reviewed 190 randomized clinical trials --103 on biomedical interventions and 87 on non-biomedical interventions (such as psychosocial interventions like the effect of group therapy on patient outcomes).

The authors found that quality of life measures were most useful for clinical decisions in trials using non-biomedical interventions.

They also found that quality of life measurements should be included as a possible endpoint in adjuvant therapy trials only when the medical outcome is expected to be about the same, if the study focuses on a vulnerable population such as the elderly, or if it tests a new intervention for which quality of life information needs to be obtained. Quality of Life measures should also be included in metastatic breast cancer trials when a minimal survival difference is expected or treatments have substantial differences in toxicity.

SOURCE: Journal of the National Cancer Institute, published online January 7, 2010