Cluster randomized controlled trial of decision support for breast cancer chemoprevention, MiCHOICE.
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Crew Katherine D, Anderson Garnet L, Arnold Kathryn B, Dzingle Sam, Michel Alissa, DeLucie Michael, Law Cynthia W, Pruthi Sandhya, Sandoval Leon Ana C, Shirley Rachel, Grosse Perdekamp Maria T, Colonna Sarah V, Krisher Stacy L, King Tari A, Yee Lisa D, Ballinger Tarah J, Braun-Inglis Christa, Mangino Debra A, Wisinski Kari B, DeYoung Claudia A, Ross Masey, Floyd Justin D, Kaster Andrea, VanderWalde Lindi H, Saphner Thomas J, Zarwan Corrine, Lo Shelly, Graham Cathy, Conlin Alison K, Yost Butler Kathleen, Agnese Doreen M, Jernigan Cheryl, Hershman Dawn L, Neuhouser Marian L, Zell Jason A, Arun Banu, Kukafka Rita
Аннотация
METHODS: We conducted a cluster randomized controlled trial to evaluate the effect of a patient-facing decision aid (RealRisks) and provider tool (BNAV) compared to standard education on the number of women with high-risk breast lesions making informed choices. Questionnaires were administered at baseline, 6 and 12 months. The primary outcome was chemoprevention informed choice (defined as adequate knowledge and attitudes congruent with decision) at 6 months. Secondary endpoints included breast cancer risk perceptions, worry, chemoprevention knowledge, decision conflict, and chemoprevention decision.
RESULTS: Across 31 randomized sites, we enrolled 210 providers, who were primarily breast health specialists. Twenty-four sites (14 intervention, 10 control) enrolled 412 patients. Among 287 patients evaluable for the primary outcome, there were no significant differences in informed choice between the intervention and control arms at 6 months (35% vs 27%, respectively; p = 0.20) and 12 months (37% vs 25%, respectively; p = 0.05). At 6 months, women in the intervention compared to control arm were more likely to have accurate breast cancer risk perceptions (31% vs 21%, respectively; p = 0.03) and adequate chemoprevention knowledge (33% vs 23%, respectively; p = 0.04). At 12 months, 52% of women in the control and 50% in the intervention arm self-reported initiating chemoprevention.
CONCLUSION: Decision support led to modest improvements in accurate risk perceptions and chemoprevention knowledge, but not informed choice. Relatively high chemoprevention uptake was achieved among women with high-risk breast lesions managed mainly by breast health specialists.
TRIAL REGISTRATION: NCT04496739.