Proactive Outreach and Streamlined Genetic Testing in Prostate Cancer Survivors (PC-CHAT)/Expanding Genetic Access and Guided Education for Prostate Cancer Survivors (ENGAGE)
The overarching goal of this trial is to test whether proactive and streamlined genetic service delivery in lieu of traditional genetic counseling referral can increase genetic testing uptake among prostate cancer survivors and how best to deliver this information. Specifically, we will compare enhanced usual care genetic referral (EUC) to genetic education via print materials plus streamlined access to genetic testing (Print+) to genetic education via an interactive digital guide plus streamlined genetic testing access (DG+) among prostate cancer survivors who meet guidelines for germline genetic testing. Our specific aims and hypotheses are:
1) Evaluate the impact of Print+ and DG+ vs. EUC. H1.1: Compared to EUC, participants randomized to both the Print+ and DG+ arms will be more likely to complete GT. H1.2: Compared to Print+, participants randomized to DG+ will be more likely to complete GT. H1.3: Compared to Print+, participants randomized to DG+ will be less likely to request pre-test GC prior to GT. Exploratory: Evaluate the impact of Print+ and DG+ on family communication among tested men and cascade GT among men with a PV.
2: Evaluate the impact of Print and DG on psychosocial and informed decision-making outcomes. H2.1: Compared to Print+, participants randomized to DG+ will have improved decision and psychosocial outcomes reflected by higher decision satisfaction, lower distress, and less decisional conflict and regret. Both Print+ and DG+ will have better decision and psychosocial outcomes than EUC.
3: Evaluate mechanisms and moderators. H3.1: Consistent with the EPPM, risk and efficacy perceptions, fear arousal, and motivation will mediate increased GT in the Print+ and DG+ arms. H3.2: Consistent with ICM, increased knowledge and more positive GT attitudes will mediate the beneficial impacts of Print+ and DG+ on decision outcomes. H3.3: Explore survivor-level factors (e.g., race) that moderate the impact of Print+ and DG+.
- Rutgers University
Inclusion Criteria: - 18-80 years of age - At least 6-months post diagnosis with prostate cancer - Have not had genetic testing for hereditary cancer - Have received care at one of the participating sites in the prior five years - Meet National Comprehensive Cancer Network criteria for germline GT - Able to read and speak in English - Capable of providing informed consent - Have internet access (via smartphone, tablet or computer) - Comfortable using a computer or mobile phone independently to access information Exclusion Criteria: - Do not speak English - Unable to access the Internet - Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT) - Are unable to provide informed consent
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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