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Responses to Genetic Risk Modifier Testing among Women with BRCA1/2 Mutations
Trial Status: active
This study investigates responses to genetic risk modifier testing among women with BRCA1/2 mutations. Genetic risk modifier testing may give women with BRCA1/2 gene mutations more specific breast cancer risk estimates.
Inclusion Criteria
Completed full sequence or targeted genetic testing with a clinically confirmed BRCA1 or BRCA2 deleterious mutation identified
No personal history of breast cancer
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
Exclusion Criteria
Previous receipt of any prophylactic mastectomy
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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03396341.
I. To determine the impact of genetic risk modifier testing on newly diagnosed BRCA1/2 mutation carriers' decisional conflict with respect to their intention to undergo preventive mastectomy or to pursue surveillance.
II. To examine the effects of different genetic risk modifier test results (i.e., magnitude of the polygenic risk score) on BRCA1/2 mutation carriers’ psychological and behavioral outcomes.
III. To describe the extent to which BRCA1/2 mutation carriers choose against learning novel genetic risk modifier test results.
OUTLINE:
Patients undergo collection of saliva samples genotyped via clinical-grade platform for genetic modifier testing.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationMemorial Sloan Kettering Cancer Center
