BRCA Founder OutReach (BFOR) Study

N/AActive Not RecruitingNCT03351803

Memorial Sloan Kettering Cancer Center5,412 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,412

Conditions

BRCA1 Mutation BRCA2 Mutation

Interventions

BFOR Digital Health solution/Web PortalOTHER

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.

Eligibility

Sex: ALLMin age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

University of California, Los Angeles

Los Angeles, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Memorial Sloan - Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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