BRCA Founder OutReach (BFOR) Study

NCT03351803 | Active Not Recruiting

• 1 other identifier: 17-568
• Study Type: observational
• Target: 5,412
• Locations: 1 country
• Sites: 5

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.

Conditions

BRCA1 Mutation; BRCA2 Mutation

Keywords

BRCA; BFOR; Ashkenazi; 17-568

Outcome Measures

Primary Outcomes (5)

• Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing

  Up to 1 year

• 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

  Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.

  Up to 1 year

• Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process

  Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process

  Up to 1 year

• Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication

  Written survey for health and diagnostic updates

  Up to 1 year

Study Arms (1)

Participants with Ashkenazi ancestry

Other: BFOR Digital Health solution/Web Portal

Interventions

BFOR Digital Health solution/Web Portal OTHER

A digital health solution with Internet-based participant recruitment and ascertainment is a mechanism for distributing access to genetic testing to populations who might not otherwise have access. For this project, LifeLink will build a private web-portal designed by the PI's of the study as described in this protocol, including the wireframes that are in the appendices, that will enable secure contact between study participants and the participating commercial laboratory (Quest Diagnostics) and BFOR researchers, as well as facilitate contacts between study participants and their primary care providers and/or a list of BFOR study centers and BFOR providers.

Participants with Ashkenazi ancestry

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be invited to join the BFOR study through information provided to their PCPs by the testing laboratories, and media and community outreach. The study will also be promoted through search engines and by genetics providers who are aware of the study. Approach to the study will be entirely participant-initiated and controlled.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Breast Cancer Research Foundation: collaborator
• Quest Diagnostics-Nichols Insitute: collaborator
• LIFELINK.COM INC: collaborator
• Memorial Sloan Kettering Cancer Center: lead
• Dana-Farber Cancer Institute: collaborator
• University of Pennsylvania: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• University of California, Los Angeles: collaborator

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Related Publications (2)

• Pace LE, Tung N, Lee YS, Hamilton JG, Gabriel C, Revette A, Raja S, Jenkins C, Braswell A, Morgan K, Levin J, Block J, Domchek SM, Nathanson K, Symecko H, Spielman K, Karlan B, Kamara D, Lester J, Offit K, Garber JE, Keating NL. Challenges and Opportunities in Engaging Primary Care Providers in BRCA Testing: Results from the BFOR Study. J Gen Intern Med. 2022 Jun;37(8):1862-1869. doi: 10.1007/s11606-021-06970-8. Epub 2021 Jun 25.

  PMID: 34173196 DERIVED

• Pace LE, Lee YS, Tung N, Hamilton JG, Gabriel C, Raja SC, Jenkins C, Braswell A, Domchek SM, Symecko H, Spielman K, Karlan BY, Lester J, Kamara D, Levin J, Morgan K, Offit K, Garber J, Keating NL. Comparison of up-front cash cards and checks as incentives for participation in a clinician survey: a study within a trial. BMC Med Res Methodol. 2020 Aug 17;20(1):210. doi: 10.1186/s12874-020-01086-9.

  PMID: 32807084 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Kenneth Offit, MD, MPH

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 24, 2017
• Study Start: November 10, 2017
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

US (5)