Decision Support for Chemoprevention

November 4, 2026 updated by: Rita Kukafka, Columbia University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Chemoprevention Uptake
Time Frame: 12 months after randomization

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beliefs about medication
Time Frame: Baseline, 6 months, 12 months

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
Time Frame: Baseline, 6 months, and 12 months

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
Time Frame: Baseline, 6-months and 12-months

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
Time Frame: Baseline, 6 months, and 12 months

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
Time Frame: Baseline, 6-month, and 12-month

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
Time Frame: Baseline, 6 months, and 12 months

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
Time Frame: Baseline, 6 months, and 12 months

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
Time Frame: Baseline, 6 months, and 12 months

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
Time Frame: Baseline, 6 months, and 12 months

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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived usefulness of RealRisks
Time Frame: 6 months and 12 months

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
Time Frame: 6 months and 12 months

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rita Kukafka, DrPH, MA, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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