Document Type
Article
Publication Date
3-7-2024
Abstract
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: The analytic data set includes primary outcome data from 315 participants (GC [n = 162] and webtool [n = 153]). Mean difference in decisional conflict score changes between groups was -0.04 (one-sided 95% CI, -∞ to 2.54; P = .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 of cancer genetics was higher but attitudes toward GT were less favorable in the webtool arm.
CONCLUSION: The results of the TARGET study support the use of patient-driven digital webtools for expanding access to pretest genetic education for PCA GT. Further studies to optimize patient experience and evaluate them in diverse patient populations are warranted.
Recommended Citation
Loeb, Stacy; Keith, Scott; Cheng, Heather; Leader, Amy; Gross, Laura; Sanchez Nolasco, Tatiana; Byrne, Nataliya; Hartman, Rebecca; Brown, Lauren; Pieczonka, Christopher; Gomella, Leonard; Kelly, William Kevin; Lallas, Costas; Handley, Nathan; Mille, Patrick; Mark, James; Brown, Gordon; Chopra, Sameer; McClellan, Alexandra; Wise, David; Hollifield, Lucas; and Giri, Veda, "TARGET: A Randomized, Noninferiority Trial of a Pretest, Patient-Driven Genetic Education Webtool Versus Genetic Counseling for Prostate Cancer Germline Testing" (2024). Department of Urology Faculty Papers. Paper 86.
https://jdc.jefferson.edu/urologyfp/86
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
38452310
Language
English
Comments
This article is the author's final published version in JCO Precision Oncology, Volume 8, March 2024, Article number e2300552.
The published version is available at https://doi.org/10.1200/PO.23.00552.
Copyright © 2024 by American Society of Clinical Oncology