Breast cancer prevention in community clinics: will low-income Latina patients participate in clinical trials?

Background Latinas have low rates of participation in breast cancer prevention trials. We evaluated the feasibility and effectiveness of a randomized trial of brief counseling and print materials compared to print materials alone to increase intent to participate in a breast cancer prevention trial. Methods We enrolled 450 women Spanish-speaking women from three urban community primary care clinics. The outcome was intent, defined as might, probably, or definitely would enroll in the trial. We also examined results using a more stringent definition restricted to probably and definitely intend to participate. Results The trial was feasible within these busy clinics, and 96% of women agreed to participate. The level of breast cancer knowledge was fairly high (66% correct answers), but understanding about clinical trials was lower (40.5% correct answers). Using the less stringent criteria for intent, 72% of women stated that they intended to enroll in the STAR trial if eligible, but rates of intent decreased to 52% with framing that included medication side effects and 45% if uterine cancer was mentioned (P < 0.01 for trend). Using the more stringent definition, slightly fewer than half of the women indicated an interest in participating, with the same trend towards decreasing intent with increasing presentation of side effects. The intervention was only effective using the less stringent definition and if no side effects were mentioned (77% intent vs. 67% in the intervention and control groups, respectively, P = 0.03). Intention was independently associated with greater worry about breast cancer and younger age, but not acculturation or knowledge. Conclusions Latina women are interested in participating in clinical trials to prevent breast cancer, although interest declines with increasing discussion of side effects. Unfortunately, brief education only increased rates of intention using the least stringent definition and when no side effects were presented in framing the question. Future work should focus on qualitative research to understand the theoretical foundations of preventive health behaviors in this population.