Expanding Genetic Access for Prostate Cancer Survivors (ENGAGE)

May 25, 2026 updated by: Marc D Schwartz, Georgetown University

Expanding Genetic Access and Guided Education for Prostate Cancer Survivors

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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).

Research Procedures:

The design for this study is a 3-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC), DG+ or Print+ in a 1:2:2 ratio - with 100 participants randomized to EUC (control) arm and 200 randomized the each of the intervention arms (DG+ and Print+).

The investigators will utilize the EHRs at our participating sites to identify prostate cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC) and MedStar Washington Cancer Institute (MWCI) in DC and 2) Rutgers' Cancer Institute (in New Brunswick and at University Hospital Newark) including RWJ Barnabas Health community oncology sites. Participants will be men who have a history of prostate cancer, are at least six-months post-diagnosis, and have received care at one of the participating sites in the prior five years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers University/Rutgers Cancer Institute
        • Contact:
        • Principal Investigator:
          • Anita Kinney, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Enhanced Usual Care
Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.
Other Names:
  • EUC
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.
Behavioral: Print 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.
Other Names:
  • Print+
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.
Behavioral: Digital 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.
Other Names:
  • DG+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of Germline Genetic Testing
Time Frame: 6-Months
As captured via internal RedCap form for the number or count of participants who opt for genetic testing during the six-month study period. The investigators will compare the three study arms to evaluate efficacy of the DG+ and Print+ interventions compared to EUC and to each other.
6-Months
Survey Assessment of Impact of DG+ vs. Print+ vs. EUC
Time Frame: 1-Month and 6-Month surveys
Evaluate the impact of the DG+ vs. Print+ vs. EUC on informed decision-making and psychosocial outcomes via survey measures of related constructs at 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
1-Month and 6-Month surveys
Survey Assessment of Mediators and Moderators of Efficacy
Time Frame: Baseline, 1-Month and 6-Month surveys
Explore potential mechanisms by assessing mediators and moderators of efficacy via survey measures of related constructs at baseline, 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
Baseline, 1-Month and 6-Month surveys

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey Assessment of Engagement with Genetic Education
Time Frame: 1-Month Survey
Engagement with genetic education/counseling via survey measures of related constructs at 1-month survey. Multiple scales are used to measure this outcome and each scale has a unique scoring system.
1-Month Survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

National Cancer Institute (NCI)
Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 30, 2029

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

May 25, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-08-272
  • R01CA296911 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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