Barriers to clinical trials. Part II: Knowledge and attitudes of potential participants.

The reasons why less than 3% of cancer patients receive treatment in a clinical trial are complex and multiply determined. Because an individual cannot sign herself into a research study, an understanding of the doctor-patient interaction must be considered in addition to individual patient dynamics. Patients may be concerned that a physician's primary allegiance is to the requirements of the trial, not the specific health needs of the individual.

Mastectomy versus conservative surgery and radiation therapy. Psychosocial consequences.

Background: Clinical trials comparing mastectomy to conservative surgery plus radiation therapy in the treatment of breast cancer have provided an opportunity to increase understanding of the biology of this disease and the psychological adaptation of the breast cancer patient. Because these local treatments appear to be equal in terms of survival, the question remains as to whether conservative surgery plus radiation therapy confers a measure of psychological comfort superior to that of mastectomy for women diagnosed with early-stage breast cancer.

Methods: One hundred forty-two women participating in a clinical trial randomizing patients to mastectomy or lumpectomy and radiation therapy were prospectively evaluated for psychological response to their respective local therapy.