NCT07899151|Not Yet Recruiting
Decision Support for Chemoprevention
Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
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Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
Sponsor study identifier
Secondary identifiers
interventional
240
1 country
1
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 1, 2026
Actual (reported)October 27, 2026
Actual (reported)September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Chemoprevention Uptake
The primary outcome is to compare the uptake of breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) at 12 months among women at high-risk for breast cancer assigned to standard educational materials alone or combined with the web-based decision aid, RealRisks. Assessed by EHR log and self-report
12 months after randomization
Beliefs about medication
Baseline, 6 months, 12 months
Perceived Breast Cancer Risk
Baseline, 6 months, and 12 months
Perceived Cardiovascular Disease Risk
Baseline, 6-months and 12-months
Accuracy of Perceived Breast Cancer Risk
Baseline, 6 months, and 12 months
Accuracy of Perceived Cardiovascular Disease Risk
Baseline, 6-month, and 12-month
Perceived usefulness of RealRisks
6 months and 12 months
Acceptability of RealRisks
6 months and 12 months
Standard educational materials regarding breast cancer chemoprevention.
Standard educational materials plus access to the RealRisks web-based decision aid. RealRisks provides personalized breast cancer and ASCVD risk assessment, educational modules, and individualized action planning.
Columbia University Irving Medical Center
New York, New York, 10032, United States
Rita Kukafka, DrPH, MA
Columbia University
First Submitted
October 1, 2026
First Posted
October 27, 2026
Study Start
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
September 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 27, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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