BRCA Founder OutReach (BFOR) Study

Study Overview
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Brief Summary
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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.

Official Title
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BRCA Founder OutReach (BFOR) Study

Conditions
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BRCA1 Mutation, BRCA2 Mutation

Intervention / Treatment
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* Other: BFOR Digital Health solution/Web Portal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Ashkenazi ancestry<br> | Other: BFOR Digital Health solution/Web Portal<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRCA, BFOR, Ashkenazi, 17-568