What this study is
Simplified from ClinicalTrials.govTesting electronic tools that give information and reminders to patients and their healthcare providers, to see if they increase use of medicines such as tamoxifen that may help lower breast cancer risk, in women ages 40 to 79 who are at high risk.
Read the original summary from ClinicalTrials.gov
The purpose of this study is to find out whether electronic tools that provide information and reminders to people at high risk for breast cancer and their healthcare providers can increase the use of medications, such as tamoxifen, that may help lower the risk of developing breast cancer. The study will also look at how these tools can be successfully used as part of routine medical care.
What's being tested
- RealRisks Decision Aid
Intervention · BEHAVIORAL
Behavioral/Educational Material
Study details
- Official title
- Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
- Sponsor
- Columbia University
- Conditions
- Breast Cancer
- Enrolling
- 240 people
- Starts
- 2026-10-07
- Est. completion
- 2028-09
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 40 Years – 79 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- Women, age 40-79 years (ages which overlap for the BCSC and ASCVD risk calculators)
- 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
- English- or Spanish-speaking
- Has a clinician affiliated with NYP/CUIMC
- Able to provide written, verbal or online informed consent
You can't join if
- Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openColumbia University Irving Medical Center
New York, New York, United States
- Research Nurse Navigator · Contactcancerclinicaltrials@cumc.columbia.edu
- Contact212-342-5162
Recruiting
Study team
Sponsor
Columbia University
Study ID AAAV2148
Principal investigator
Rita Kukafka, DrPH, MA
Columbia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.