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Randomized Controlled Trial
. 2024 Mar:8:e2300552.
doi: 10.1200/PO.23.00552.

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

Stacy Loeb  1   2   3   4 , Scott W Keith  5 , Heather H Cheng  6   7 , Amy E Leader  8 , Laura Gross  9   10 , Tatiana Sanchez Nolasco  1   2   4 , Nataliya Byrne  1   2   4 , Rebecca Hartman  5 , Lauren H Brown  7 , Christopher Michael Pieczonka  11 , Leonard G Gomella  12 , William Kevin Kelly  8 , Costas D Lallas  12 , Nathan Handley  8   13 , Patrick Johnston Mille  8 , James Ryan Mark  12 , Gordon Andrew Brown  14 , Sameer Chopra  14 , Alexandra McClellan  10 , David R Wise  3 , Lucas Hollifield  3 , Veda N Giri  9   15
Affiliations
Randomized Controlled Trial

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

Stacy Loeb et al. JCO Precis Oncol. 2024 Mar.

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.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/po/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Veda N. Giri

This author is a member of the JCO Precision Oncology Editorial Board. Journal policy recused the author from having any role in the peer review of this manuscript.

Stock and Other Ownership Interests: Novopyxis

Honoraria: Ambry Genetics

No other potential conflicts of interest were reported.

Multiple regression imputation was used to replace missing data with expected values consistent with the null hypothesis of inferiority of WBGE to traditional GC. The predictors in the longitudinal mixed-effect regression models constructed to estimate the imputed decisional conflict values included study site, study group assignment, time indicator (T2 v T1), race, current PCA status, alcohol consumption (≥six drinks/wk v fewer), age at PCA diagnosis, BMI, and time × study group interaction.

Figures

FIG 1.
FIG 1.
TARGET study CONSORT diagram. n = 315 people who answered the T1 survey had primary outcome data. TARGET, technology-enhanced acceleration of germline evaluation for therapy; WBGE, web-based genetic education via patient-driven webtool.
FIG 2.
FIG 2.
Study-adjusted mean difference effect estimates with 95% confidence limits. Estimates represent the mean difference between study groups WBGE (patient-driven webtool) minus traditional genetic counseling treatment groups in terms of change in scores (T2 minus T1), except for satisfaction scores, which were analyzed only at T2. The shaded region corresponds to the noninferiority rejection region for the primary end point, decisional conflict (–∞ to 4). WBGE, web-based genetic education via patient-driven webtool.
See this image and copyright information in PMC

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