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ACTIVE NOT RECRUITING
NCT05325151
NA

Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

Summary

This stage I clinical trial compares a genetic counseling patient preference (GCPP) intervention via EHR MyChart patient portal to conventional genetic counseling for women at elevated risk for breast cancer. Women at elevated breast cancer risk may be offered genetic counseling and genetic testing to further define whether they are at high risk (e.g. hereditary risk; BRCA mutation positive); moderate risk (e.g. risk based largely on family history and/or polygenic risk score) or average risk (e.g. general population). Genetic counseling may improve basic genetic knowledge, produce more accurate risk perceptions and tailor recommendations for greater perceived personal control regarding breast cancer risk. A single approach to genetic counseling may not fit the needs for all patients, and genetic counseling models that increase access to genetic testing and are more patient-centered may better serve patients. This trial may help researchers determine if a GCPP intervention can take the place of conventional genetic counseling, while being non-inferior in terms of adherence to screening recommendations, breast cancer genetic knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling compared to conventional genetic counseling. Study results will provide the efficacy for using a novel cancer genetic counseling approach via EHR MyChart patient portal that will be readily adaptable to other health care systems in the future, inform best practices, and reduce workforce burden.

Official title: A Randomized Controlled Trial Comparing a Genetic Counseling Patient Preference Intervention vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer

Key Details

Gender

FEMALE

Age Range

30 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

874

Start Date

2022-06-13

Completion Date

2026-03-30

Last Updated

2025-12-11

Healthy Volunteers

Yes

Interventions

OTHER

Educational Intervention

Receive GCPP intervention videos

OTHER

Genetic Counseling

Receive genetic counseling

OTHER

Survey Administration

Ancillary studies

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States