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).
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Fallowfield LJ, Baum M, Maguire GP (1986) Effects of breast conservation on psychological morbidity associated with diagnosis and treatment of early breast cancer. Br Med J 293:1331–1334CrossRefGoogle Scholar
Lasry JCM et al. (1987) Depression and body image following mastectomy and lumpecto-my. J Chronic Dis 40: 529–534PubMedCrossRefGoogle Scholar
Schain W et al. (1983) Psychosocial and physical outcomes of primary breast cancer therapy: mastectomy vs excisional biopsy and irradiation. Breast Cancer Res Treat 3: 377–382PubMedCrossRefGoogle Scholar
Scheurlen H, Olschewski M, Leibbrand D (1984) Zur Methodologie kontrollierter klinischer Studien über die Primärbehandlung des operablen Mammakarzinoms. Strahlentherapie 160: 459–468PubMedGoogle Scholar