Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study

Study Overview
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Brief Summary
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The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.

Detailed Description
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Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies. This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis). The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.

Official Title
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Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Other: RealRisks
* Other: BNAV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 5-year breast risk of 1.67% or lifetime risk of 20% according to the Gail model The participant understands and is willing to provide informed consent in English or Spanish Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital Exclusion Criteria: Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention Prior history of breast cancer

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Decision aid<br>50 women at high-risk for developing breast cancer will use a decision support tool, RealRisks, when discussing breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool. | Other: RealRisks<br>* RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.<br>* Other names: RealRisks patient-centered decision aid (DA);Other: BNAV<br>* Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.<br>* Other names: BNAV provider clinical decision support tool;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the accuracy of risk perception (Likert Scale Score) | To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale. | Baseline, 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in a patient's breast cancer knowledge (Survey Score) | To assess patient's breast cancer knowledge before and after exposure to the RealRisks decision aid by comparing the difference between a patient's responses to a 13-item scale assessing knowledge with response options of true, false, or unsure. | Baseline, 2 weeks | 
| Chemoprevention uptake rate among high-risk women | To determine the uptake rate in the breast clinic after offering specialized risk counseling to a broader population of racially/ethnically diverse women screened in the primary care setting. Electronic health records will be used to track chemoprevention uptake after exposure to the RealRisks decision aid. | 6 months | 
| Referral rates to the breast clinic | To study appropriate referral rate by primary care providers of high-risk patients to the breast clinic. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Prevention, Risk Assessment, Chemoprevention, Decision Making