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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2022-08-31

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.

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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.

Conditions

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Breast Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Decision Aid

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.

Group Type EXPERIMENTAL

RealRisks

Intervention Type OTHER

RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.

BNAV

Intervention Type OTHER

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.

Control Group

Women at high risk for developing breast cancer will receive standard breast health education brochures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RealRisks

RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.

Intervention Type OTHER

BNAV

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.

Intervention Type OTHER

Other Intervention Names

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RealRisks patient-centered decision aid (DA) Breast Cancer Risk Navigation (BNAV) tool BNAV provider clinical decision support tool

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