Clinical trial · Interventional
Expanding Genetic Access for Prostate Cancer Survivors
Expanding Genetic Access and Guided Education for Prostate Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Genetic Testing | — | UNRESOLVED | — |
| Hereditary Cancer | Hereditary Malignant Neoplasm | ALIAS | 0.90 |
| Prostate Cancer Patients | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Guide Genetic Education Guide | Behavioral | — | UNRESOLVED |
| Enhanced Usual Care | Behavioral | — | UNRESOLVED |
| Print Genetic Education Guide | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care (EUC)
- description
- Participants in the EUC arm will be mailed a clinical letter. The letter sent to EUC participants will inform them of their own and their family's potential risk for carrying a pathogenic variant (PV) related to hereditary cancer. The letter will emphasize their eligibility for GT, include a recommendation to consider scheduling a GC appointment to obtain more information, and include a link to the Rutgers Cancer Institute or LCCC high-risk clinic website. The study team will help facilitate GT when requested by the participant. Results will be shared with the participant, their oncologist and tailored per the result.
- interventionNames
- Behavioral: Enhanced Usual Care
- type
- EXPERIMENTAL
- label
- Print Genetic Education plus Streamlined Genetic Testing (Print+)
- description
- Participants in the Print+ arm will receive a clinical letter from the institution's clinical genetics program along with a copy of the print education guide and a genetic testing kit. The print guide provides detailed information regarding risk for hereditary cancer and options for genetic testing comparable to the information conveyed in traditional genetic counseling (GC). Information is conveyed through a combination of text, infographics, and images. Print+ participants who wish to proceed directly to GT can request an out-of-pocket cost estimate and then return the GT kit directly to the testing lab. Results will be shared with the participant, their oncologist and tailored per the result. Participants who indicate that they are unsure or do not want GT will be encouraged to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available