Expanding Genetic Access for Prostate Cancer Survivors

Conditions

• Genetic Testing
• Hereditary Cancer
• Prostate Cancer Patients

Eligibility Criteria

Sex

MALE

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Print Genetic Education Guide — BEHAVIORAL
  Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.
• Digital Guide Genetic Education Guide — BEHAVIORAL
  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.
• Enhanced Usual Care — BEHAVIORAL
  Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.

Study Details

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.

Key Dates

Start date

Aug 1, 2026

Status verified

May 2026

Primary completion

Jul 30, 2029

Completion

Jul 31, 2030

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Enhanced Usual Care (EUC)
  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.
• Experimental: Print Genetic Education plus Streamlined Genetic Testing (Print+)
  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.
• Experimental: Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+)
  Participants in the DG+ arm will receive a clinical letter from the institution's clinical genetics program with a link to the RA along with a genetic testing kit. The fully HIPAA-compliant DG will provide comparable educational information to traditional genetic counseling (GC) but in a streamlined and tailored manner including video, education and decision support, patient testimonial and answers to questions in real-time. Participants will be informed that they may speak to a genetic risk specialist free of charge. Participants who wish to proceed directly to GT can indicate this within the DG. They will be provided with a GT out-of-pocket cost estimate before returning the GT kit. 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 by RA to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.

Primary Outcome Measure

Uptake of Germline Genetic Testing [ Time Frame: 6-Months ]

Central Contacts

• Marc Schwartz
  202-687-0185
  [email protected]

Locations (2)

Find similar trials in Washington D.C., DC

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