Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care

Thomas B Silverman,Awilda Marte,Rita Kukafka,Margaret Sin,Alejandro Vanegas,Jennie Mata,Wei-Yann Tsai,Juan Carlos Rodriguez Ramirez,Katherine D Crew

doi:10.1186/s12913-018-3442-x

Thomas B Silverman, Awilda Marte + Show 7 more

Open Access

https://doi.org/10.1186/s12913-018-3442-x

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Abstract

BackgroundBRCA1 and BRCA2 mutations confer a substantial breast risk of developing breast cancer to those who carry them. For this reason, the United States Preventative Services Task Force (USPSTF) has recommended that all women be screened in the primary care setting for a family history indicative of a mutation, and women with strong family histories of breast or ovarian cancer be referred to genetic counseling. However, few high-risk women are being routinely screened and fewer are referred to genetic counseling. To address this need we have developed two decision support tools that are integrated into clinical care.MethodThis study is a cluster randomized controlled trial of high-risk patients and their health care providers. Patient-provider dyads will be randomized to receive either standard education that is supplemented with the patient-facing decision aid, RealRisks, and the provider-facing Breast Cancer Risk Navigation Toolbox (BNAV) or standard education alone. We will assess these tools’ effectiveness in promoting genetic counseling uptake and informed and shared decision making about genetic testing.DiscussionIf found to be effective, these tools can help integrate genomic risk assessment into primary care and, ultimately, help expand access to risk-appropriate breast cancer prevention options to a broader population of high-risk women.Trial registrationThis trial is retrospectively registered with ClinicalTrials.gov Identifier: NCT03470402: 20 March 2018.

Highlights

BRCA1 and BRCA2 mutations confer a substantial breast risk of developing breast cancer to those who carry them
Hereditary breast and ovarian cancer syndrome (HBOC) is an inherited condition that is most often associated with mutations in the BRCA1 and BRCA2 (BRCA1/2) genes [3]
Our aim is to conduct a cluster randomized controlled trial to evaluate the effect of patient education with RealRisks and Breast Cancer Risk Navigation Toolbox (BNAV) compared to patient education alone on promoting appropriate uptake of BRCA1/2 genetic counseling

Summary

Introduction

BRCA1 and BRCA2 mutations confer a substantial breast risk of developing breast cancer to those who carry them For this reason, the United States Preventative Services Task Force (USPSTF) has recommended that all women be screened in the primary care setting for a family history indicative of a mutation, and women with strong family histories of breast or ovarian cancer be referred to genetic counseling. Hereditary breast and ovarian cancer syndrome (HBOC) is an inherited condition that is most often associated with mutations in the BRCA1 and BRCA2 (BRCA1/2) genes [3] Carriers of these pathogenic mutations face a lifetime breast. In order to promote the identification of women carrying BRCA1/2 mutations, the United States Preventive Services Task Force (USPSTF) recommends that primary care providers screen asymptomatic women for an increased BRCA1/2 mutation risk [21]. Women who screen positive should receive genetic counseling by a trained health care provider and be offered BRCA1/2 testing if further indicated and desired after counseling [21]

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