Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention

Kevin Sweet; Paul L Reiter; Patrick M Schnell; Leigha Senter; Kate P Shane-Carson; Amber Aeilts; Julia Cooper; Christina Spears; Jordan Brown; Amanda E Toland; Doreen M Agnese; Mira L Katz

doi:10.1016/j.cct.2023.107323

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.

Authors

Affiliations

¹ Division of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA. Electronic address: kevin.sweet@osumc.edu.
² Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Health Behavior and Health Promotion, College of Public Health, The Ohio State University, Columbus, OH, USA.
³ Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Biostatistics, College of Public Health, The Ohio State University, Columbus, OH, USA.
⁴ Division of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA.
⁵ Division of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Division of Bioethics, Department of Biomedical Education and Anatomy, The Ohio State University, Columbus, OH, USA.
⁶ Division of Human Genetics, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA; Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Department of Cancer Biology and Genetics, College of Medicine, The Ohio State University, Columbus, OH, USA.
⁷ Comprehensive Cancer Center, The Ohio State University, Columbus, OH, USA; Department of Surgery, College of Medicine, The Ohio State University, Columbus, OH, USA.

PMID: 37661005
PMCID: PMC10591709 (available on 2024-10-01)
DOI: 10.1016/j.cct.2023.107323

Abstract

Background: Genetic counseling and testing have an important role in the care of patients at elevated risk for breast cancer. However, conventional pre- and post-test genetic counseling is labor and time intensive, less accessible for patients living outside major urban centers, and impractical on a large scale. A patient-driven approach to genetic counseling and testing may increase access, improve patients' experiences, affect efficiency of clinical practice, and help meet workforce demand. The objective of this 2-arm randomized controlled trial is to determine the efficacy of Know Your Risk (KYR), a genetic counseling patient preference intervention.

Methods: Females (n = 1000) at elevated risk (>20% lifetime) for breast cancer will be randomized to the KYR intervention or conventional genetic counseling. The study will provide comprehensive assessment of breast cancer risk by multigene panel testing and validated polygenic risk score. Primary outcome is adherence to National Comprehensive Cancer Network guidelines for a clinical encounter every 6-12 months and an annual mammogram (breast MRI if recommended) determined by medical record review. Secondary outcomes include adherence to other recommended cancer screening tests determined by medical record review and changes in breast cancer knowledge, perception of risk, post-test/counseling distress, and satisfaction with counseling by completion of three surveys during the study. Study aims will be evaluated for non-inferiority of the KYR intervention compared to conventional genetic counseling.

Conclusion: If efficacious, the KYR intervention has the potential to improve patients' experience and may change how genetic counseling is delivered, inform best practices, and reduce workforce burden.

Trial registration: ClinicalTrials.govNCT05325151.

Keywords: Breast cancer; Genetic counseling; Genetic testing; Patient education; Polygenic; Randomized controlled trial.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Breast Neoplasms* / diagnosis
Breast Neoplasms* / genetics
Breast Neoplasms* / psychology
Counseling
Female
Genetic Counseling* / methods
Genetic Counseling* / psychology
Genetic Testing / methods
Humans
Randomized Controlled Trials as Topic
Risk Factors

Associated data

ClinicalTrials.gov/NCT05325151

Abstract

Publication types

MeSH terms

Associated data

Grants and funding