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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Other: RealRisks; Other: BNAV

• Registration Number: NCT02954900
• Lead Sponsor: Columbia University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-03-15
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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Exclusion Criteria

• Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
• Prior history of breast cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Decision aid	BNAV	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.
Decision aid	RealRisks	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.

Primary Outcome Measures

Name	Time	Method
Change in the accuracy of risk perception (Likert Scale Score)	Baseline, 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Chemoprevention uptake rate among high-risk women	6 months	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.
Referral rates to the breast clinic	12 months	To study appropriate referral rate by primary care providers of high-risk patients to the breast clinic.
Change in a patient's breast cancer knowledge (Survey Score)	Baseline, 2 weeks	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States