Scalable Communication Modalities for Returning Genetic Research Results

NCT ID: NCT04407611

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 932 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2026-03-31

Brief 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.

Detailed 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.

Conditions

Hereditary Breast and Ovarian Cancer; Lynch Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conventional modality

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Online modality

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

Group Type: EXPERIMENTAL

Online modality

Intervention Type: BEHAVIORAL

Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to

Genetic counselor follow-up

Intervention Type: BEHAVIORAL

Optional genetic counselor follow-up over the telephone

Interventions

Online modality

Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to

Intervention Type: BEHAVIORAL

Genetic counselor follow-up

Optional genetic counselor follow-up over the telephone

Intervention Type: BEHAVIORAL

Other Intervention Names

Web modality

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

MGH Institute of Health Professions

OTHER

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catharine Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

BU School of Public Health

Locations

BU School of Public Health, the research is being conducted remotely

Boston, Massachusetts, United States

Countries

United States

References

Wang C, Bertrand KA, Trevino-Talbot M, Flynn M, Ruderman M, Cabral HJ, Bowen DJ, Hughes-Halbert C, Palmer JR. Ethical, legal, and social implications (ELSI) and challenges in the design of a randomized controlled trial to test the online return of cancer genetic research results to U.S. Black women. Contemp Clin Trials. 2023 Sep;132:107309. doi: 10.1016/j.cct.2023.107309. Epub 2023 Jul 27.

Reference Type: DERIVED

PMID: 37516165 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MD014312

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-40045

Identifier Type: -

Identifier Source: org_study_id