RecruitingNCT03396341

Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

400 participants

Start Date

Jan 4, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this study is to describe how women with BRCA1/2 mutations react to genetic risk modifier testing, and to examine how they make decisions about their healthcare.


Eligibility

Sex: FEMALEMin Age: 25 Years

Inclusion Criteria4

  • Female patient, age 25 years or older (given that women under this age are not generally recommended to receive BRCA1/2 genetic testing)
  • 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 Criteria3

  • 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.

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Interventions

OTHERSalvia sample

salvia sample

BEHAVIORALQuestionnaires

Participants will complete Assessment #1 questionnaires. Participants will be contacted 1 week later (+/- 1 week) to complete Assessment #2 questionnaires. Participants will be contacted 6 months (+/- 3 weeks) following the receipt of their genetic risk modifier results to complete Assessment #3 questionnaires. Participants will be encouraged to complete Assessments #2 and #3 via email using the secure, approved REDCap system


Locations(7)

Dana Farber Cancer Institute (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Abramson Cancer Center at University of Pennsylvania Medical Center (Data Collection Only)

Philadelphia, Pennsylvania, United States

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NCT03396341


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