Genetic Education in BRCA Families

NCT03544983 | Enrolling By Invitation DMC

• 1 other identifier: 2018-0439
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

BRCA1 Mutation; BRCA2 Mutation

Keywords

Breast Cancer; Ovarian Cancer; Prostate Cancer; BRCA1; BRCA2

Outcome Measures

Primary Outcomes (1)

• Uptake of genetic counseling and testing

  The proportion of participants who complete genetic counseling and testing

  6-months post randomization

Secondary Outcomes (4)

• Patient Reported Outcomes Measurement Information System -- Anxiety

  1- and 6-months post-randomization

• Patient Reported Outcomes Measurement Information System -- Depression

  1- and 6-months post-randomization

• Decisional Conflict Scale

  1- and 6-months post-randomization

• Multidimensional Impact of Cancer Risk Scale - Uncertainty Scale

  6-months post-randomization

Study Arms (2)

Proactive Outreach + Web Counseling

EXPERIMENTAL

Web + Streamlined Telephone Genetic Information

Behavioral: Web + Streamlined Telephone Genetic Information

Usual Care

NO INTERVENTION

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.

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.

Proactive Outreach + Web Counseling

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A first- (sibling, adult offspring) or second-degree (aunt/uncle, niece/nephew if at-risk parent is deceased) biological relative of an individual with a recently identified BRCA1 or BRCA2 mutation

You may not qualify if:

• Personal diagnosis of metastatic cancer
• Prior genetic testing for hereditary breast/ovarian cancer
• Have one or more children who have tested positive for a BRCA1 or BRCA2 mutation
• Cannot participate in or understand English
• Cannot provide meaningful informed consent

Sponsors & Collaborators

• Georgetown University: lead
• George Washington University: collaborator

Study Sites (4)

Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marc D Schwartz, PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed via electronic survey and review of medical records. In cases where surveys need to be completed by telephone, the outcomes assessor will be blind to the participant's randomization.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology, Associate Director for Population Science

Model Details: Two group parallel design comparing Web-based education + streamlined telephone genetic information session to usual care.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: May 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)