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