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BRCA Founder OutReach (BFOR) Study (BFOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03351803
Recruitment Status : Active, not recruiting
First Posted : November 24, 2017
Last Update Posted : November 5, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
BRCA1 Mutation BRCA2 Mutation Other: BFOR Digital Health solution/Web Portal

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Study Type : Observational
Actual Enrollment : 5412 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BRCA Founder OutReach (BFOR) Study
Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : May 10, 2021
Estimated Study Completion Date : May 10, 2021

Group/Cohort Intervention/treatment
Participants with Ashkenazi ancestry Other: BFOR 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.




Primary Outcome Measures :
  1. Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing [ Time Frame: Up to 1 year ]
  2. 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 ]
  3. Psychosocial impact of genetic population screening utilizing a digital health solution [ Time Frame: Up to 1 year ]
    Quality of life questionnaires measuring cancer-specific distress, perceived risk and BRCA 1/2 testing knowledge will be used.

  4. Facilitators and barriers to engaging primary care providers (PCPs) in the BRCA1/2 results disclosure process [ Time Frame: Up to 1 year ]
    Post-disclosure PCP survey will be used to assess facilitators and barriers in the disclosure process

  5. Participant health updates in personal familial cancer diagnosis and genetic testing depending on method of results communication [ Time Frame: Up to 1 year ]
    Written survey for health and diagnostic updates



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351803


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Kenneth Offit, MD, MPH Memorial Sloan Kettering Cancer Center
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03351803    
Other Study ID Numbers: 17-568
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
BRCA
BFOR
Ashkenazi
17-568