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BRCA Founder OutReach (BFOR) Study (BFOR)

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ClinicalTrials.gov Identifier: NCT03351803
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Cedars-Sinai Medical Center
Dana-Farber Cancer Institute
University of Pennsylvania
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Breast Cancer Research Foundation
Quest Diagnostics
LIFELINK.COM INC
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
Estimated Enrollment : 4000 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, 2020
Estimated Study Completion Date : May 10, 2020

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


Contacts
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Contact: Kenneth Offit, MD, MPH 646-888-4059 offitk@mskcc.org
Contact: Mark Robson, MD 646-888-5434 robsonm@mskcc.org

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Beth Karlan, MD    310-794-9728      
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Judy Garber, MD, MPH    617-632-5961      
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nadine Tung, MD    617-667-7081      
United States, New York
Memorial Sloan - Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Kenneth Offit, MD, MPH    646-888-4059      
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Susan Domchek, MD    215-615-5858      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Cedars-Sinai Medical Center
Dana-Farber Cancer Institute
University of Pennsylvania
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Breast Cancer Research Foundation
Quest Diagnostics
LIFELINK.COM INC
Investigators
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Principal Investigator: Kenneth Offit, MD, MPH Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03351803     History of Changes
Other Study ID Numbers: 17-568
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
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
Additional relevant MeSH terms:
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Pharmaceutical Solutions