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| Name | Class |
|---|---|
| CureBRCA Foundation | UNKNOWN |
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The purpose of this study is to learn how people with BRCA1/2 mutations respond to genetic risk modifier testing. The researchers will learn more about how people make choices about their health care, including about methods to screen for prostate cancer. Researchers are also doing this study to learn about how the genetic risk modifier test affects people's thoughts and feelings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Men with BRCA1/2 mutations who are at risk for prostate cancer | Will be offered genetic risk modifier testing (note that this testing is of clinical grade but is not yet standard of care and is therefore only available through the context of this research study), and will complete baseline and then 1-week, 6-month, and 12-month post-receipt of modifier results follow-up quantitative assessments of their psychological and behavioral outcomes. Participants will also be asked to complete the standard CGS Family History Questionnaire, once their baseline assessment is completed. This information will be used to inform genetic counsellors/study doctors during the patients' genetic risk modifier testing results disclosure appointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cheek (buccal) swab | Genetic | swab sample in person or at home with a mailed test kit and will fill out a survey |
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| Measure | Description | Time Frame |
|---|---|---|
| Intention to undergo prostate cancer screening options | Change in intention for each screening option measured with the Choice predisposition scale. Choice Predisposition scale ranges from 1 (leaning towards yes) to 15 (leaning towards no) regarding a specific option. | 6 months |
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Inclusion Criteria:
Documentation of Disease
o Patients must not have prostate cancer (for individuals not presently receiving care at the study site, this information will be based on self-report.)
Age between 45 - 70;
Assigned male sex at birth for individuals not presently receiving care at the study site, this information will be based on self-report.)
Completed full sequence or targeted genetic testing with a result confirmed in a clinically approved laboratory showing a BRCA1/2 likely pathogenic or pathogenic variant identified, or clinician note documents a BRCA1/2 likely pathogenic or pathogenic variant
English-fluent; the surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.(for individuals not presently receiving care at the study site, this information will be based on self-report.)
Exclusion Criteria:
Prostate cancer
Potential participants (i.e., male MSK patients with a documented BRCA1/2 PV) will be identified by study staff who will screen relevant clinic schedules (e.g., for the MSK CATCH high-risk screening clinic, for post-test visits in the MSK CGS) and approached by their clinician (primary genetic counselor, and/or clinician in the high-risk screening clinic or other MSK clinician) with support from study staff. Or non-MSK patients (e.g., community members) who are referred to the study by study clinicians.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jada Hamiliton, PhD, MPH | Contact | 646-888-0049 | hamiltoj@mskcc.org | |
| Kenneth Offit, MD | Contact | 646-888-4050 |
| Name | Affiliation | Role |
|---|---|---|
| Jada Hamilton, PhD, MPH | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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cheek (buccal) swab
| Assessments | Other | about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys. |
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| optional collection of blood | Other | for research testing |
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