Comprehensive Genetic Assessment, Risk and Education among Women at Intermediate or High Risk of Breast Cancer, CARE at Mammography Study
- Women participating in Institutional Review Board (IRB):18-010601 * Aged 35 and over with a negative routine mammogram within 3 months * Qualifies as intermediate or high-risk (> 15% lifetime risk of breast cancer as defined by IBIS version 8)
- Have an active email address for survey completion
- Not participating in the Contrast Enhanced Digital Mammogram (CEDM) pilot
- Known genetic cancer syndrome with test results available for review in Mayo electronic medical records (EMR)
- Known breast cancer
- Unable to understand or sign informed consent
I. To determine the prevalence of genetic mutations in this intermediate/high risk population of women presenting for screening mammography.
I. To evaluate the update of genetic testing by intermediate/high risk patients at mammography.
II. To evaluate genetic literacy, decisional conflict and decisional latency amongst this population using focused surveys.
Patients receive pre-test genetic counseling via pre-recorded video per standard of care. After watching the pre-test counseling video, patients have the option to undergo genetic testing. Patients who agree to undergo genetic testing, undergo collection of blood and saliva samples for testing. Patients also complete a survey regarding experience with the genetic testing process and factors that influence patient decisions to undergo genetic testing after genetic testing and within 2-4 weeks after receipt of genetic results. Patients who forego genetic testing after watching the video, complete a survey regarding decisional conflict, latency, attitudes surrounding video pre-test counseling.
Trial Phase Phase NA
Trial Type Screening
Mayo Clinic in Arizona
Niloy Jewel Samadder
- Primary ID 19-004343
- Secondary IDs NCI-2021-02684
- Clinicaltrials.gov ID NCT04002986