TARGET: A Randomized, Noninferiority Trial of a Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling for Prostate Cancer Germline Testing

作者：Stacy Loeb, Scott W. Keith, Heather H. Cheng, Amy E. Leader, Laura Gross, Tatiana Sanchez Nolasco, Nataliya K. Byrne, Rebecca L. Hartman, Lauren H. Brown, Christopher Michael Pieczonka, Leonard G. Gomella, William Kevin Kelly, Costas D. Lallas, Nathan R. Handley, Patrick Johnston Mille, James Ryan Mark, Gordon Andrew Brown, Sameer S Chopra, Alexandra McClellan, David R. Wise, Lucas Hollifield, Veda N. Giri · 发表于：JCO Precision Oncology · 年份：2024 · DOI：10.1200/po.23.00552 · 被引用次数：11 · 研究领域：BRCA gene mutations in cancer、Genomics and Rare Diseases、Prostate Cancer Diagnosis and Treatment

PURPOSE: Germline genetic testing (GT) is important for prostate cancer (PCA) management, clinical trial eligibility, and hereditary cancer risk. However, GT is underutilized and there is a shortage of genetic counselors. To address these gaps, a patient-driven, pretest genetic education webtool was designed and studied compared with traditional genetic counseling (GC) to inform strategies for expanding access to genetic services. METHODS: Technology-enhanced acceleration of germline evaluation for therapy (TARGET) was a multicenter, noninferiority, randomized trial (ClinicalTrials.gov identifier: NCT04447703) comparing a nine-module patient-driven genetic education webtool versus pretest GC. Participants completed surveys measuring decisional conflict, satisfaction, and attitudes toward GT at baseline, after pretest education/counseling, and after GT result disclosure. The primary end point was noninferiority in reducing decisional conflict between webtool and GC using the validated Decisional Conflict Scale. Mixed-effects regression modeling was used to compare decisional conflict between groups. Participants opting for GT received a 51-gene panel, with results delivered to participants and their providers. RESULTS: = .01), suggesting the patient-driven webtool was noninferior to GC. Overall, 145 (89.5%) GC and 120 (78.4%) in the webtool arm underwent GT, with pathogenic variants in 15.8% (8.7% in PCA genes). Satisfaction did not differ significantly between arms; knowledge...