Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 300
- Locations
- 2
- Primary Endpoint
- Chemoprevention uptake rate among high-risk women
Study Overview
Brief Summary
The purpose of this randomized controlled trial (RCT) is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer prevention options. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigators hypothesize that improving accuracy of breast cancer risk perception and understanding of the risks and benefits of breast cancer risk lowering drugs, also known as chemoprevention, will increase the uptake of chemoprevention in the primary care setting.
Detailed Description
Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators' inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.
The investigators hypothesize that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake. We anticipate that the BNAV tool will facilitate referrals to the breast clinic by primary care providers (PCPs) and that the RealRisks decision aid will prime high-risk women to seek these referrals. The primary endpoint is uptake of a selective estrogen receptor modulator (SERM) or Aromatase inhibitor (AI) for breast cancer chemoprevention at 6 months (after the next primary care appointment) in the active arm compared to usual care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •5-year breast cancer risk ≥ to 1.67% or lifetime risk ≥ to 20% according to the Gail risk model; or a 5-year breast cancer risk ≥ 1.67% according to the Breast Cancer Surveillance Consortium (BCSC) model
- •The participant understands and is willing to provide informed consent in English or Spanish
- •Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital
Exclusion Criteria
- •Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
- •Prior history of breast cancer
Outcomes
Primary Outcomes
Chemoprevention uptake rate among high-risk women
Time Frame: 6 months (after the next primary care visit)
The primary endpoint is to determine the uptake rate of a SERM or AI medication for breast cancer chemoprevention at 6 months (after the next primary care visit) in the active arm compared to usual care (control arm). Electronic health records will be used to track chemoprevention uptake after exposure to the intervention, the RealRisks decision aid, or the control, standard standard breast health education brochures.
Secondary Outcomes
- Chemoprevention intention rate among high-risk women (Likert Scale Score)(1 month)
- High-risk referral rates to the breast clinic(6 months (after the next primary care visit))
- Completion of high-risk consultations at the breast clinic(6 months (after the next primary care visit))
Investigators
Katherine D. Crew
Associate Professor of Medicine and Epidemiology
Columbia University
