Expanding Genetic Access and Guided Education for Prostate Cancer Survivors
Georgetown University
Summary
The goal of this study is to increase genetic education and genetic testing for hereditary cancer risk among prostate cancer survivors. The study will: Test the effectiveness of a digital guide (DG+) vs. print guide (Print+) vs. enhanced usual care (EUC) on engagement in genetic education and uptake of genetic testing. Evaluate the impact of the DG+ vs. Print+ vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes). Explore the ways (methods) that influence how participants experience the intervention. The main questions this study aims to answer are: which group - the digital guide (DG+) group, print (Print+) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education. Participants will be randomly assigned to either the digital guide (DG+) group, the print guide (Print+) group or EUC group. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the three groups to determine which is most most likely to complete genetic testing (GT) and which group engages more with genetic education.
Description
Research Design and Methods: This study will employ a 3-arm parallel group randomized controlled trial to evaluate the efficacy of the DG+ and Print+ interventions compared to EUC among 500 prostate cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the interventions on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3). Resea…
Eligibility
- Age range
- 18–80 years
- Sex
- Male
- Healthy volunteers
- No
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 * Ha…
Interventions
- BehavioralPrint Genetic Education Guide
Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.
- BehavioralDigital Guide Genetic Education Guide
Consists of clinical letter, genetic testing kit, and access to a genetic education digital guide along with streamlined access to genetic testing for hereditary cancer risk.
- BehavioralEnhanced Usual Care
Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.
Locations (2)
- Georgetown University Medical Center/Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Rutgers University/Rutgers Cancer InstituteNew Brunswick, New Jersey