BRCA1 Mutation, BRCA2 Mutation
Conditions
Keywords
BRCA, BFOR, Ashkenazi, 17-568
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.
Interventions
OTHERBFOR Digital Health solution/Web Portal
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Dana-Farber Cancer Institute
University of Pennsylvania
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Breast Cancer Research Foundation
Quest Diagnostics-Nichols Insitute
LIFELINK.COM INC
University of California, Los Angeles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 1 year | Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used. |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth Offit, MD, MPH
Memorial Sloan Kettering Cancer Center
Outcome results
None listed