A DECISION SUPPORT INTERVENTION TO INCREASE PARTICIPATION IN BREAST CANCER CLINICAL TRIALS

Purpose:  Advances in cancer treatment are largely dependent on clinical trial participation; trials are a major channel for translating novel scientific findings into clinical practice.  However, numerous barriers to clinical trial participation exist, and participation remains low.  We used an online decision support tool to clarify breast cancer patients’ personal preference for or against trial participation and facilitate shared decision making.

Method: Women newly diagnosed with breast cancer completed a baseline survey at a scheduled office visit prior to meeting with their oncologist. The survey assessed respondent knowledge and perceptions about clinical trials in general, decisional conflict about enrolling in a trial, and sociodemographic background.  A trained health educator used an online Decision Counseling Program^© (DCP) to review information about clinical trials, and elicited self-reported factors affecting preference for participation.  A one-page report that displayed these factors and computed preference was generated for review by the patient and her clinician during the ensuing encounter.  A research assistant administered a telephone survey at 30 days to measure patient knowledge, decisional conflict related to trial participation, and perceived importance of trial participation.  A 90-day medical chart audit documented whether the clinician offered the patient a clinical trial and if the patient enrolled.

Result: Characteristics of 27 participants were: < 60 years of age (69%), White (66%), > high school education (81%), and living with a partner (47%).  Patients identified a total of 77 factors affecting trial participation preference. The most common factor favoring participation was the belief that clinical trials are important; while the most common factor favoring non-participation was concern about undergoing additional medical procedures.  At 30 days, women reported higher levels of knowledge about clinical trials (p<0.01) and were less likely to feel uncertain, uninformed, and unclear in decision making about participation than at baseline (p < 0.001).  In addition, the perceived importance of participating in a trial increased significantly (p<0.05).  Clinicians offered trials to only 7 patients and 5 (71%) enrolled. 

Conclusion: Participants who were exposed to decision counseling exhibited increased knowledge, a stronger belief in the value of clinical trials, and decreased decisional conflict about participation.  Participation was high among those who were offered a trial. Future research should further assess the effects of decision counseling and shared decision making on trial participation.