Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists

Purpose: To improve understanding of physicians' reluctance to refer patien ts to clinical trials. Methods: This study was conducted in a large metropolitan region from 1993 to 1995 using a two-staged population-based sampling strategy. A total of 1 47 physicians discussed 245 patient cases and their own knowledge, attitude s, and practices toward clinical trials, Results: Ninety-three patients (38.0%) were offered a trial, and 49 (52.7%) of them agreed to participate. Forty-five patients (18.4%) actually receiv ed their adjuvant therapy on trial. Older patients and those with a poorer prognosis were less likely to be referred. Patients who delayed their decis ion were more than three times as likely to participate in a trial and more than eight times as likely to participate when they were reported to be ac tively involved in making the decision. Generally, physicians in university settings and who held formal support from a cooperative group were more li kely to refer patients to trials. More specifically, surgeons referred more patients to trials when they felt comfortable explaining trials or believe d that treatment should not stray from protocol, Oncologists were less like ly to make referrals if they perceived the paperwork to be onerous or entry requirements to be too stringent. Surgeons' participation in recommending adjuvant therapy to patients resulted in more trial referrals unless they t reated their patients with tamoxifen. Conclusion: (1) Physicians still need to overcome attitudinal and practical barriers to trial participation, (2) more support for physicians is needed , (3) surgeons may play a pivotal role in the recruitment of patients to ad juvant therapy trials, and (4) garnering patient enthusiasm for trial parti cipation and involving them in the choice of adjuvant therapy may be key co mponents to increasing trial enrollment. (C) 2000 by American Society of Cl inical Oncology.