Scalable Communication Modalities for Returning Genetic Research Results (BWHS RoR)

Boston University

Status: Active, not recruiting

Conditions: Lynch Syndrome; Hereditary Breast and Ovarian Cancer

Treatments: Behavioral: Genetic counselor follow-up; Behavioral: Online modality

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04407611

R01MD014312 (U.S. NIH Grant/Contract)

H-40045

Details and patient eligibility

About

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.

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.

Enrollment: 932 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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932 participants in 2 patient groups

Conventional modality

No Intervention group

Description:

Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.

Online modality

Experimental group

Description:

Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.

Treatment:

Behavioral: Online modality

Behavioral: Genetic counselor follow-up