Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting

Study Overview
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Brief Summary
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The purpose of this randomized controlled trial (RCT) is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer prevention options. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigators hypothesize that improving accuracy of breast cancer risk perception and understanding of the risks and benefits of breast cancer risk lowering drugs, also known as chemoprevention, will increase the uptake of chemoprevention 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. The investigators hypothesize 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. We anticipate that the BNAV tool will facilitate referrals to the breast clinic by primary care providers (PCPs) and that the RealRisks decision aid will prime high-risk women to seek these referrals. The primary endpoint is uptake of a selective estrogen receptor modulator (SERM) or Aromatase inhibitor (AI) for breast cancer chemoprevention at 6 months (after the next primary care appointment) in the active arm compared to usual care.

Official Title
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Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial

Conditions
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Breast Neoplasm

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 cancer risk ≥ to 1.67% or lifetime risk ≥ to 20% according to the Gail risk model; or a 5-year breast cancer risk ≥ 1.67% according to the Breast Cancer Surveillance Consortium (BCSC) 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision Aid<br>Women at high risk for developing breast cancer will use a decision support tool, RealRisks, that facilitates discussion of 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;|
| No Intervention: Control Group<br>Women at high risk for developing breast cancer will receive standard breast health education brochures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemoprevention uptake rate among high-risk women | The primary endpoint is to determine the uptake rate of a SERM or AI medication for breast cancer chemoprevention at 6 months (after the next primary care visit) in the active arm compared to usual care (control arm). Electronic health records will be used to track chemoprevention uptake after exposure to the intervention, the RealRisks decision aid, or the control, standard standard breast health education brochures. | 6 months (after the next primary care visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemoprevention intention rate among high-risk women (Likert Scale Score) | Behavioral intention for chemoprevention will be assessed one month after baseline among those in the active arm compared to patients receiving usual care (control arm). | 1 month | 
| High-risk referral rates to the breast clinic | To study appropriate referral rate to the breast clinic by primary care providers of high-risk patients in the active arm compared to patients receiving usual care (control arm). | 6 months (after the next primary care visit) | 
| Completion of high-risk consultations at the breast clinic | To study appointment completion rate at the breast clinic by high-risk patients in the active arm compared to patients receiving usual care (control arm). | 6 months (after the next primary care visit) | 

 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