Clinical trial NCT03351803: BRCA Founder OutReach (BFOR) Study
Official title: BRCA Founder OutReach (BFOR) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: BRCA1 Mutation
BRCA2 Mutation
Keywords: BRCA
BFOR
Ashkenazi
17-568
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: University of Pennsylvania
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Breast Cancer Research Foundation
name: Quest Diagnostics-Nichols Insitute
name: LIFELINK.COM INC
name: University of California, Los Angeles
First posted: 2017-11-24
Enrollment: 5412
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
timeFrame: Up to 1 year
measure: Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff
timeFrame: Up to 1 year
measure: Psychosocial impact of genetic population screening utilizing a digital health solution
timeFrame: Up to 1 year
measure: Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process
timeFrame: Up to 1 year
measure: Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan - Kettering Cancer Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kenneth Offit, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.