BRCA Founder OutReach (BFOR) Study

Active, not recruiting

• Conditions: BRCA1 Mutation; BRCA2 Mutation
• Interventions: Other: BFOR Digital Health solution/Web Portal

• Registration Number: NCT03351803
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to learn how to provide BRCA gene testing to a larger number of people as well as to make testing part of a person's regular medical care.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-10
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-05-10
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5412

Inclusion Criteria

• Self-reported age ≥ 25
• Self identify as having at least one of their four grandparents as Ashkenazi Jewish
• Has medical insurance
• Able to understand and read the English-language
• Zip code falls within the catchment areas of the phase of the study (e.g. New York City, Boston, Philadelphia, Los Angeles) accessible to a BFOR designated provider

Exclusion Criteria

• Under age 25
• No Ashkenazi Jewish ancestry
• Does not have insurance
• Has previously had medical BRCA testing ordered by a health care provider

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with Ashkenazi ancestry	BFOR Digital Health solution/Web Portal	-

Primary Outcome Measures

Name	Time	Method
Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing	Up to 1 year
Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process	Up to 1 year	Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process
Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication	Up to 1 year	Written survey for health and diagnostic updates
Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff	Up to 1 year
Psychosocial impact of genetic population screening utilizing a digital health solution	Up to 1 year	Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.

Trial Locations

Locations (5)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Memorial Sloan - Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States