Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomization to 1 of 2 study arms.
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Conventional modality 		Control arm. Conventional modality entails telephone disclosure of genetic results by a licensed genetic counselor.
Experimental
Online modality 		Online self-guided modality entails return of genetic results directly to participants, with optional genetic counselor follow-up via telephone.
  • Behavioral: Online modality
    Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to
    Other names:
    • Web modality
  • Behavioral: Genetic counselor follow-up
    Optional genetic counselor follow-up over the telephone

More Details

Status
Active, not recruiting
Sponsor
Boston University

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.