Breast CancerNCT07899151
Decision Support for Chemoprevention
A study testing RealRisks Decision Aid in people with Breast Cancer, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 79 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- RealRisks Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- English- or Spanish-speaking
- Has a clinician affiliated with NYP/CUIMC
- Able to provide written, verbal or online informed consent
Who cannot join
- Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
Rita Kukafka, DrPH, MA, 212-305-1945, rk326@cumc.columbia.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- RealRisks Decision Aid
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RealRisks Decision AidBehavioural
Behavioral/Educational Material
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard educational materials regarding breast cancer chemoprevention. |
| Intervention | Experimental | 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. Receives: Behavioral: RealRisks Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months after randomization
Secondary outcomes (9)
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.
Measured: 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%
Measured: 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%.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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').
Measured: 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:____
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Rita Kukafka, Columbia University
- Investigators
- Rita Kukafka, DrPH, MA, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899151
- Sponsor's protocol ID
- AAAV2148
- Other IDs
- 5R01CA293927-03
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Breast Cancer and Cardiovascular Disease Risk to Explore Decision-Making for Chemoprevention Among Women at High Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT07899151
- Acronym / sponsor ID
- AAAV2148
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard educational materials regarding breast cancer chemoprevention. |
| Intervention | Experimental | Behavioral: RealRisks Decision AidStandard 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. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- English- or Spanish-speaking
- Has a clinician affiliated with NYP/CUIMC
- Able to provide written, verbal or online informed consent
Key exclusion criteria (1 listed)
- Patients who have a prior history of invasive breast cancer or ductal carcinoma in situ are ineligible to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RealRisks Decision AidBehavioral/Educational Material | Behavioural | Intervention |
Primary outcome
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
9 secondary outcomes
Beliefs about medication
Time frame: Baseline, 6 months, 12 months
Perceived Breast Cancer Risk
Time frame: Baseline, 6 months, and 12 months
Perceived Cardiovascular Disease Risk
Time frame: Baseline, 6-months and 12-months
Accuracy of Perceived Breast Cancer Risk
Time frame: Baseline, 6 months, and 12 months
Accuracy of Perceived Cardiovascular Disease Risk
Time frame: Baseline, 6-month, and 12-month
Informed Choice
Time frame: Baseline, 6 months, and 12 months
Decision Conflict
Time frame: Baseline, 6 months, and 12 months
Intention or decision about chemoprevention uptake
Time frame: Baseline, 6 months, and 12 months
Factors influencing intention about chemoprevention
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rita Kukafka, DrPH, MA principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RealRisks Decision Aid in people with Breast Cancer, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Nurse Navigator (212-342-5162, cancerclinicaltrials@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemoprevention Uptake (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.