Genetic Education in BRCA Families

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Georgetown University
Study ID
NCT03544983
Status
Enrolling By Invitation

Conditions

  • BRCA1 Mutation
  • BRCA2 Mutation

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Web + Streamlined Telephone Genetic Information — BEHAVIORAL
    Tailored and interactive web-based education designed to incorporate all aspects of standard genetic counseling followed by a streamlined genetic counseling session with a board-certified genetic counselor.

Study Details

The primary goal of this research is to test a web-based genetic education intervention that is designed to educate men and women from hereditary cancer families about the personal relevance of genetic testing in order to help them male decisions about whether to pursue genetic testing. We will test this intervention against standard care for men and women from hereditary cancer families. The web-based educational intervention includes all of the information typically covered during genetic counseling. As a result, after completing the education intervention, participants can proceed directly to a brief telephone call with a genetic counselor followed by testing if they choose. A baseline survey will be administered prior to randomization and then follow-up surveys will be administered at 1-month and 6-months post-randomization. Primary outcomes will be completion of genetic counseling, uptake of genetic testing, genetic test results and quality of life.

Key Dates

Start date
May 1, 2020
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Proactive Outreach + Web Counseling
    Web + Streamlined Telephone Genetic Information
  • No Intervention: Usual Care
    Participants in the usual care arm will not be provided with access to the web-based intervention nor will they have access to streamlined genetic counseling. They can pursue clinical genetic counseling on their own.

Primary Outcome Measure

Uptake of genetic counseling and testing [ Time Frame: 6-months post randomization ]

Locations (4)

FacilityCityStateZIPSite coordinators
George Washington UniversityWashington D.C.District of Columbia20052-
Georgetown University Medical Center/Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Geisinger Medical CenterDanvillePennsylvania17822-

Find similar trials in Washington D.C., DC

By research site
George Washington University· Washington D.C., DCGeorgetown University Medical Center/Lombardi Comprehensive Cancer Center· Washington D.C., DCDana Farber Cancer Institute· Boston, MAGeisinger Medical Center· Danville, PA

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