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| Name | Class |
|---|---|
| Dana-Farber Cancer Institute | OTHER |
| University of Pennsylvania | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| Brigham and Women's Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Ashkenazi ancestry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BFOR Digital Health solution/Web Portal | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Offit, MD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34173196 | Derived | 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. | |
| 32807084 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| OTHER |
| Breast Cancer Research Foundation | OTHER |
| Quest Diagnostics-Nichols Insitute | INDUSTRY |
| LIFELINK.COM INC | UNKNOWN |
| University of California, Los Angeles | OTHER |
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|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Memorial Sloan - Kettering Cancer Center | New York | New York | 10021 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Derived |
| 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. |