Evaluation of psychosocial aspects in a breast preservation trial.

Our preliminary and exploratory data analysis of the current state of QOL assessment in the ongoing BMFT breast preservation trial indicates that our questionnaire meets criteria of validity, differentiability, and practicability in the context of a large multi-center trial. The results of treatment comparisons tend towards accordance with those of comparable studies, in that they do not show the often-postulated global superiority of breast-preserving therapy over mastectomy with respect to QOL. The special study concept of combining patients with and without treatment preference gives rise to a lot of methodological issues but is the only way to find out whether participation in the therapeutic decision-making process is beneficial to the patient or not.