Quality of life in breast cancer patients: measurement issues in cancer clinical trials.

Quality of life is becoming a significant issue to measure in breast cancer patients. Increasingly, in breast cancer clinical trials we see quality of life as a secondary end-point and we are understanding more about the needs of these women. However, as yet, there is no gold standard regarding which tool is the most appropriate to use. This article reviews quality of life measures that have been used in cancer clinical trials with breast cancer patients and evaluates their reliability, validity and cultural relevance. We propose suggestions for selecting future measures for use in a breast cancer population of patients.