Expanding Genetic Access for Prostate Cancer Survivors

NCT07618520 | Not Yet Recruiting

• 2 other identifiers: 25-08-272R01CA296911
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer Patients; Hereditary Cancer; Genetic Testing

Keywords

Prostate cancer; survivorship; genetic counseling; genetic testing; hereditary cancer; Chatbot

Outcome Measures

Primary Outcomes (3)

• Uptake of Germline Genetic Testing

  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

  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

  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 Outcomes (1)

• Survey Assessment of Engagement with Genetic Education

  1-Month Survey

Study Arms (3)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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

Print Genetic Education plus Streamlined Genetic Testing (Print+)

EXPERIMENTAL

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

Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+)

EXPERIMENTAL

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

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.

Also known as: Print+

Print Genetic Education plus Streamlined Genetic Testing (Print+)

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.

Also known as: DG+

Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+)

Enhanced Usual Care BEHAVIORAL

Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.

Also known as: EUC

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• National Cancer Institute (NCI): collaborator
• Rutgers University: collaborator

Study Sites (2)

Georgetown University Medical Center/Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Rutgers University/Rutgers Cancer Institute

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dermatoglyphics

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biometric Identification; Biometry; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Security Measures; Organization and Administration; Health Services Administration

Central Study Contacts

Marc Schwartz

CONTACT

202-687-0185; schwartm@georgetown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Treating clinicians will be blind their patients group assignment. While participants cannot be blinded to group, they will be blinded to the study's specific hypotheses. Statisticians and outcome assessors will be blinded to allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Oncology/Associate Center Director

Model Details: This study will employ a 3-arm parallel group randomized controlled trial to evaluate the efficacy of the digital guide (DG+) and print guide (Print+) interventions compared to Enhanced Usual Care (EUC) among 500 prostate cancer survivors. Randomization is at the patient level and will be balanced in a 1:2:2 ratio - with 100 participants randomized to the EUC arm and 200 participants randomized to each of the DG+ and Print+ arms. Randomization will be in blocks and stratified by recruitment site (DC, NJ). The investigators also plan to enroll a total of 16 usability testing participants across all sites.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)