Breast Cancer Clinical Trial

Scalable Communication Modalities for Returning Genetic Research Results

Summary

Efforts to examine the utility of alternate modalities for genetic results disclosure has widespread implications for how precision medicine research might yield direct health benefits for study participants. This study will examine the efficacy of an online self-guided program to return genetic results to a racial minority cohort population. Study results will provide empirical evidence on the effectiveness of alternate modalities for genetic results return, inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women.

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Full Description

This study is a randomized controlled trial (RCT) within the Black Women's Health Study (BWHS) to test alternate communication modalities for results disclosure. The BWHS is an ongoing prospective cohort study of 59,000 self-identified black women from across the United States who have been followed since 1995. Targeted sequencing of over 4000 women within the cohort for BRCA1/2 and other known or suspected high and moderate penetrance genes opens up the possibility of returning breast cancer genetic results to BWHS participants and examining the clinical utility of genetic results return. The primary aim of the proposed research project is to compare the efficacy of two communication modalities for returning breast cancer genetic research results to African American women: 1) a conventional modality that entails telephone disclosure by a licensed genetic counselor, and 2) an online self-guided modality that entails returning results directly to participants, with optional genetic counselor follow-up via telephone. Secondary aims of this study will examine 1) moderators of the intervention impact and 2) psychosocial, sociodemographic, and clinical predictors of result uptake. This study is uniquely situated to provide critical empirical evidence on the effectiveness of alternate models for genetic results return and provide further insight into the factors influencing uptake of genetic information among African American women.

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Eligibility Criteria

Inclusion Criteria:

-Women in the BWHS previously included in the targeted breast cancer sequencing project

Exclusion Criteria:

Women with known cognitive impairments
Women with variant of uncertain significance (VUS) results from the sequencing study

Study is for people with:

Breast Cancer

Estimated Enrollment:

2275

Study ID:

NCT04407611

Recruitment Status:

Recruiting

Sponsor:

Boston University

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There is 1 Location for this study

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BU School of Public Health, the research is being conducted remotely
Boston Massachusetts, 02118, United States More Info
Catharine Wang, PhD
Contact
[email protected]

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Study is for people with:

Breast Cancer

Estimated Enrollment:

2275

Study ID:

NCT04407611

Recruitment Status:

Recruiting

Sponsor:


Boston University

How clear is this clinincal trial information?

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