Evaluation of Psychosocial Aspects in a Breast Preservation Trial

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Abstract
The aim of a controlled clinical trial is usually to compare the efficacy of an innovative treatment with that of an established standard therapy. In cancer clinical trials the survival time of patients, i. e., the time from entry into the trial until death or recurrence, is the most important end point. This variable gives an objective description of what happens to the patient. However, both the disease and the treatment also have a subjective impact on the patient. To combine both objective and subjective viewpoints for a comprehensive appreciation of treatment effects we must take psychosocial factors into consideration — the latter are commonly referred to as the “quality of life” (QOL).