BACKGROUND: Breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) is under-utilized despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Reasons for low chemoprevention uptake include inadequate time for counseling, insufficient knowledge about SERMs and AIs, and concerns about side effects. Intervention trials of clinical decision support tools designed to increase chemoprevention uptake have been met with limited success. We have developed web-based decision aids (DAs), RealRisks for high-risk women and BNAV for primary care providers (PCPs). Our intervention differs from the prior literature in that we are targeting both patients and PCPs with personalized risk reports and education about the risks and benefits of chemoprevention. Our patient-centered decision aid is available in English and Spanish and has been rigorously tested in multi-ethnic women with varying health literacy. We hypothesize that standard educational materials combined with RealRisks and BNAV will increase uptake of SERMs or AIs among high-risk women in the primary care setting.
TRIAL DESIGN: We are conducting a randomized controlled trial at Columbia University Medical Center (CUMC) in New York, NY, consisting of standard educational materials combined with RealRisks and BNAV or standard educational materials alone among 300 high-risk women stratified by Hispanic ethnicity and menopausal status. Women in the intervention arm are given access to the RealRisks DA, and, based on their responses, an action plan is generated summarizing their breast cancer risk profile, risks/benefits of SERMs and AIs, and personal preferences for chemoprevention. PCPs are given their patient's tailored risk report, which is the providers' view of the action plan, and are invited to access the BNAV tool.
ELIGIBILITY CRITERIA: 1) Women, aged 35-75 years; 2) 5-year invasive breast cancer risk ≥1.67% or lifetime risk ≥20% according to the Gail model (Breast Cancer Risk Assessment Tool) or history of lobular carcinoma in situ; 3) No prior use of SERM or AI; 4) No prior history of breast cancer; 5) PCP at CUMC; 6) English- or Spanish-speaking.
SPECIFIC AIMS: The primary endpoint is chemoprevention uptake of a SERM or AI at 6 months based upon documentation in the electronic health record. Secondarily, we use validated surveys to assess breast cancer and chemoprevention knowledge, accuracy of perceived breast cancer risk and worry, decision self-efficacy, and informed choice at baseline, 1 month, 6 months, and post-clinical encounter with the patients' PCP. PCPs will complete a 1-time survey on personal and professional characteristics and practice patterns.
STATISTICAL METHODS: With a total sample size of 300 (150 per arm), assuming a Type 1 error of 5% and a 10% drop-out rate (effective sample size of 270), we will have >80% power to detect a difference in chemoprevention uptake of 1% in the control arm and 10% in the active intervention arm.
TARGET ACCRUAL: 300. Seventy-eight participants accrued as of June 2017. Accrual completion expected November 2018.
