The investigators hypothesize that pregnancy and preconception care may be a feasible and effective time to offer inherited cancer risk screening. This study will assess interest in cancer genetic testing among patients receiving routine prenatal or preconception/fertility care. The goal is to evaluate the acceptability of BRCA1/2 testing when offered alongside standard prenatal genetic screening. The study will also explore whether universal screening in this population could support early cancer prevention and be cost-effective, especially among underserved populations.
Age 18 years - 55 years
Pregnant patients receiving obstetrical-related care or receiving preconception/fertility care at a WCM-affiliated enrollment site.
Patients who have elected to undergo OCS with the WCM-affiliated obstetrics provider
Patients with prior OCS but planned to repeat OCS are eligible
Patients who have previously completed a multigene hereditary cancer syndrome panel
Patients who have a hematologic cancer or hematologic pre-cancer
Patients who have a history of an autologous bone marrow transplant
Single group
MyRisk Hereditary Cancer Test
GeneticSubjects that are planning to proceed with OCS and enrolled in the trial will be contacted by the genetics clinician (by telephone or in person, based on subject preference) to review the option for HCS in addition to OCS. The WCM genetics clinician will review the potential risks and benefits, possible findings, and implications of findings for HCS. The genetics clinician will follow WCM standards (outlined by the WCM Genetics and Personalized Cancer Prevention Program https://wcinyp.org/GPCP) for informed consent counseling on the potential risks/benefits of HCS. The counseling regarding OCS will have already been performed by the obstetrical team as part of the standard of care. The genetics clinician will review that OCS is being performed as part of the patient's standard of care prenatal visit and HCS is an additional component that is being performed as part of participation in this clinical trial.
Percentage of Participants Who Complete Both HCS and OCS
Percentage of enrolled participants who successfully complete both HCS and OCS during the study period. Completion is defined as having documented results for both screenings
Percentage of Participants Completing Both HCS and OCS, Stratified by Demographic and Clinical Characteristics
The percentage of participants who complete both HCS and OCS, stratified by patient race, ethnicity, language, gestational age, insurance provider, personal cancer history, and family cancer history. Completion is defined as having documented results for both screenings.
Percentage of High-Risk Participants Utilizing Guideline-Based Cancer Mitigation Strategies
Among participants who complete both HCS and OCS and are identified as being at elevated cancer risk, this measure captures the percentage who undergo one or more guideline-based cancer mitigation strategies, such as mammogram, breast MRI, or colonoscopy.
Participant Experience with Combined HCS and OCS measured by the NCCN Distress Thermometer
Participant experience with combined HCS and OCS will be assessed using a National Comprehensive Cancer Network (NCCN) validated scale called the Distress Thermometer. It is a single-item scale ranging from 0 (no distress) to 10 (extreme distress). A lower score indicates less distress, while a higher score signifies greater distress.
Participant Experience with Combined HCS and OCS measured by Satisfaction with Genetic Counseling Scale
Participant experience with combined HCS and OCS will be assessed using a validated Satisfaction with Genetic Counseling Scale. It is a 10-item Likert scale (1-5) assessing satisfaction with counseling, including both positively and negatively worded items (reverse-scored). Total scores range from 10 to 50, with higher scores indicating greater satisfaction.
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Weill Medical College of Cornell University
Lead sponsor
Myriad Genetics, Inc.
Collaborator
