Decision support tools to help high-risk women consider breast cancer chemoprevention
Official title: Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
Run by Columbia University · NCT07899151 · Data updated 2026-11-12
A web-based decision aid plus standard materials will see if reminders and information help high-risk women start medications like tamoxifen more often.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 79 Years |
| Sex | Women only |
| Enrollment | 240 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 7, 2026 |
| Main results expected | September 2028 |
| Study ends | September 2028 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07899151 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 40-79 who are at high risk for breast cancer and fluent in English or Spanish.
✕Probably not a fit
Participants for whom chemoprevention is not appropriate or preferred may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized trial tests whether the RealRisks decision aid, used with usual educational materials, increases uptake of chemoprevention among women at high risk for breast cancer. The intervention provides personalized breast cancer and cardiovascular risk information to support informed choices about preventive medication. The primary outcome is uptake of chemoprevention at 12 months, with secondary outcomes including beliefs about medications, risk perceptions, informed choice, and decision conflict.
Why it matters
Potential benefit: If successful, this approach could help more high-risk women decide to take chemoprevention when appropriate.
How similar studies have gone: Prior studies in decision aids suggest tools can influence preventive medicine uptake, but effectiveness for chemoprevention in this population remains to be demonstrated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators) 2. High-risk for breast cancer based upon any of the following criteria: * Histologically-confirmed atypical hyperplasia or lobular carcinoma in situ * At least a 3% breast cancer risk at 5 years or 5% risk at 10 years or 20% lifetime risk according to one of the following breast cancer risk models: Breast Cancer Surveillance Consortium risk calculator V3 (https://tools.bcsc-scc.ucdavis.edu/BC5yearRisk/#calculator), Gail Breast Cancer Risk Assessment Tool (https://bcrisktool.cancer.gov/calculator.html), Tyrer-Cuzick model V8 (https://ibis-risk-calculator.magview.com), or BOADICEA canrisk model (https://www.canrisk.org) * Known carriers of germline pathogenic/likely pathogenic variant in the following breast cancer predisposition genes (ATM, BRCA2, CHEK2, or PALB2) * Prior chest wall irradiation before age 30 years 3. English- or Spanish-speaking 4. Has a clinician affiliated with NYP/CUIMC 5. Able to provide written, verbal or online informed consent Exclusion Criteria: * Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.
Where it's running
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Columbia University Irving Medical Center
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Rita Kukafka, DrPH, MA — Columbia University
- Study coordinator: Research Nurse Navigator
- Email: cancerclinicaltrials@cumc.columbia.edu
- Phone: 212-342-5162
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.