Assessing health-related quality of life in cancer trials

In cancer clinical trials, the evaluation of treatment options is often dominated by patient survival. However, treatment improvements have permitted survival to be measured in years rather than months for many cancer patients. This trend is likely to persist and the quality of survival as reported by patients will become an increasingly important end point. Additionally, when new cancer therapies show small survival gains, the quality of this survival period from the patient perspective should be assessed in order to adequately evaluate the new agent and to inform clinicians and patients about tradeoffs in the form of treatment-related side effects. This article describes the rationale for measuring health-related quality of life outcomes in cancer trials, and key design and methodological considerations in clinical trial settings.