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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 45 Years and 70 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

  • Major psychiatric illness or cognitive impairment that in the judgment of the study investigators or study staff would preclude study participation. - Any patients who are unable to comply with the study procedures as determined by the study investigators or study staff. - Under active treatment for a malignancy. (Patients are eligible if they have a prior history of malignancy other than prostate cancer, as long as they are not currently undergoing active treatment for the malignancy) (for individuals not presently receiving care at the study site, this information will be based on self-report.) - Enrolled in NCI study 19-C-0040 (Natural History of Men at High-Risk for Prostate Cancer) based on self-report - Patients with a known pathogenic and/or likely pathogenic germline variant in any hereditary prostate cancer risk gene, excluding BRCA1 and/or BRCA2, including but not limited to: HOXB13, ATM, CHEK2, NBN, PALB2, MLH1, MSH2, MSH6, PMS2,RAD51C, RAD51D and TP53. - Any patient who has had a prostate biopsy within 36 months, according to clinician note (for individuals not presently receiving care at the study site, this information will be based on self-report)

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Genetic: cheek (buccal) swab
    swab sample in person or at home with a mailed test kit and will fill out a survey
  • Other: Assessments
    about 1 week, 6 months, and 12 months after getting the updated cancer risk assessment to complete additional surveys.
  • Other: optional collection of blood
    for research testing

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Jada Hamilton, PhD, MPH
646-888-0049

More Details

Status
Recruiting
Sponsor
Memorial Sloan Kettering Cancer Center

Study Contact

Jada Hamiliton, PhD, MPH
646-888-0049
hamiltoj@mskcc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.