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

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.

Sex

Female

Minimum age

30 Years

Maximum age

64 Years

Inclusion Criteria:

* Being female.
* Ages 30-64.
* Being an Ohio State University (OSU) patient who uses MyChart.
* Undergoing routine screening mammography.
* Normal BI-RADS1.
* At elevated breast cancer risk by the Cancer Risk Assessment (CRA) tool.
* Able to read and speak English.
* Provide consent.

Exclusion Criteria:

* Previous genetic counseling.
* Previous genetic testing for cancer risk or known mutation in a breast cancer gene: ATM, BARD1, BRCA1, BRCA2, CDH1, CHEK2, NBN, PALB2, PTEN, TP53.
* Previous diagnosis of breast or ovarian cancer or personal history of lobular carcinoma in situ (LCIS) or breast hyperplasia (with or without atypia).
* Being a member of a focus group that assisted with the development of the intervention.

• DERIVEDKatz ML, Schnell PM, Reiter PL, Senter L, Aeilts A, Spears C, Cooper J, Brown J, Shane-Carson KP, Agnese DM, Toland AE, Sweet K. Knowledge of cancer genetics and attitudes about genetic counseling and testing: a randomized trial of the Know Your Risk intervention compared to conventional genetic counseling. Cancer Causes Control. 2026 Jun 30;37(7):112. doi: 10.1007/s10552-026-02207-3. PMID 42377622
• DERIVEDSweet K, Reiter PL, Schnell PM, Senter L, Shane-Carson KP, Aeilts A, Cooper J, Spears C, Brown J, Toland AE, Agnese DM, Katz ML. Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention. Contemp Clin Trials. 2023 Oct;133:107323. doi: 10.1016/j.cct.2023.107323. Epub 2023 Sep 1. PMID 37661005