Clinical trial NCT04407611: Scalable Communication Modalities for Returning Genetic Research Results
Official title: Testing Scalable Communication Modalities for Returning Breast Cancer Genetic Research Results to African American Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hereditary Breast and Ovarian Cancer
Lynch Syndrome
Keywords: BRCA testing
Return of genetic research results
eHealth
Digital health
Risk communication
ELSI
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: MGH Institute of Health Professions
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-05-29
Enrollment: 932
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to 1 of 2 study arms.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of participant that decide to learn genetic results at 6 weeks
timeFrame: 6 weeks
measure: Number of participant that decide to learn genetic results at 6 months
timeFrame: 6 months
measure: Change from baseline in breast cancer genetics knowledge based on questionnaire at responses at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Change in baseline depression at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Depression at 6 months
timeFrame: 6 months
measure: Depression at 12 months
timeFrame: 12 months
measure: Change in baseline anxiety at 6 weeks
timeFrame: Baseline, 6 weeks
measure: Anxiety at 6 months
timeFrame: 6 months
measure: Anxiety at 12 months
timeFrame: 12 months
measure: Participant distress from cancer risk assessment (test-specific distress) at 6 weeks
timeFrame: 6 weeks
measure: Participant distress from cancer risk assessment (test-specific distress) at 6 months
timeFrame: 6 months
measure: Participant distress from cancer risk assessment (test-specific distress) at 12 months
timeFrame: 12 months
measure: Participant uncertainty from cancer risk assessment at 6 weeks
timeFrame: 6 weeks
measure: Participant uncertainty from cancer risk assessment at 6 months
timeFrame: 6 months
measure: Participant uncertainty from cancer risk assessment at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: BU School of Public Health, the research is being conducted remotely
state: Massachusetts
Study officials:
affiliation: BU School of Public Health
name: Catharine Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: