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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: RealRisks Decision Aid

Detailed Description

This randomized controlled trial will evaluate whether the web-based RealRisks decision aid, combined with standard educational materials, increases breast cancer chemoprevention uptake among women at high risk for breast cancer compared with standard educational materials alone. The intervention incorporates individualized breast cancer and cardiovascular disease risk information to support informed decision-making regarding chemoprevention. The primary endpoint is chemoprevention uptake at 12 months. Secondary outcomes include medication beliefs, breast cancer risk perceptions, informed choice, and decision conflict.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Nurse Navigator; Phone Number: 212-342-5162; Email: cancerclinicaltrials@cumc.columbia.edu
• Study Contact Backup: Name: Rita Kukafka, DrPH, MA; Phone Number: 212-305-1945; Email: rk326@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Contact: Research Nurse Navigator; Email: cancerclinicaltrials@cumc.columbia.edu
      • Contact: Phone Number: 212-342-5162

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard educational materials regarding breast cancer chemoprevention.
Experimental: Intervention; 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.	Behavioral: RealRisks Decision Aid; Behavioral/Educational Material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beliefs about medication	Beliefs in Medication Questionnaire (BMQ)adapted for use in chemoprevention decision-making. The BMQ includes the Necessity scale (10 items that assess how patients perceive their personal need for chemoprevention for reducing BC risk, maintaining their health, and preventing illness), the Concerns scale (10 items measuring concerns about potential adverse effects of chemoprevention). Participants rate the extent to which they agree with each item on a scale (scored 1- 5). The total score for each scale is computed by adding the scores for each scale item together and dividing by the number of items.	Baseline, 6 months, 12 months
Perceived Breast Cancer Risk	3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of breast cancer on a scale of 0 to 100%	Baseline, 6 months, and 12 months
Perceived Cardiovascular Disease Risk	3 items of absolute estimate, comparative risk assessed on a 3-point Likert scale, and numeric 10-year risk of cardiovascular disease on a scale of 0 to 100%.	Baseline, 6-months and 12-months
Accuracy of Perceived Breast Cancer Risk	Difference between perceived numeric risk estimate and actual 10-year risk of breast cancer risk according to the BCSC risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk	Baseline, 6 months, and 12 months
Accuracy of Perceived Cardiovascular Disease Risk	Difference between perceived numeric risk estimate and actual 10-year risk of Cardiovascular Disease Risk according to the 2013 ACA/AHA ASCVD risk calculator; Categorized as accurate if the difference between subjective and objective risk estimates are ≤5% in either direction, underestimate if >5% below objective risk, and overestimate if >5% above objective risk	Baseline, 6-month, and 12-month
Informed Choice	This measure combines the chemoprevention knowledge scale, an attitudes scale, and chemoprevention decision. Informed choice defined as 1) those who have an adequate knowledge score, a positive attitude towards chemoprevention, and decide to take chemoprevention; 2) those who have an adequate knowledge score, a negative attitude towards chemoprevention, and decide not to take chemoprevention.	Baseline, 6 months, and 12 months
Decision Conflict	Score on the 10-item Decision Conflict Scale assessing uncertainty and conflict related to decisions about chemoprevention uptake. Items are rated using three response categories: Yes (0), Unsure (2), and No (4). Scores are summed, divided by 10, and multiplied by 25. Final scores range from 0 to 100, with higher scores indicating greater conflict and lower scores indicating less conflict.	Baseline, 6 months, and 12 months
Intention or decision about chemoprevention uptake	Behavioral intentions to take chemoprevention measured using 'Given what you know right now, how likely do you think you are to take a breast cancer prevention drug in the next year?' (1 = 'not at all likely,' to 5 = 'extremely likely').	Baseline, 6 months, and 12 months
Factors influencing intention about chemoprevention	Survey item to rank the main factors influencing a patient's decision about chemoprevention: 1) Personalized risk information; 2) polypharmacy for CVD or other comorbidities; 3) Provider recommendation; 4) RealRisks DA; 5) Other:____	Baseline, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived usefulness of RealRisks	Preparation for Decision Making scale. 10-items assesses a patients perception of how useful a DA or decision support intervention is in preparing the respondent to communicate with their provider at a consultation making a health decision.	6 months and 12 months
Acceptability of RealRisks	Ottawa 10-item Acceptability questionnaire includes questions evaluating comprehensibility, sufficiency of information, and overall suitability of the DA for decision making.	6 months and 12 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Rita Kukafka, DrPH, MA, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: October 1, 2026
• First Submitted That Met QC Criteria: October 23, 2026
• First Posted (Actual): October 27, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AAAV2148; 5R01CA293927-03 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No