Prostate Cancer PatientsENGAGENCT07618520
Expanding Genetic Access for Prostate Cancer Survivors
A study testing Print Genetic Education Guide and Digital Guide Genetic Education Guide in people with Prostate Cancer Patients and Hereditary Cancer, run by Georgetown University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Patients, Hereditary Cancer, Genetic Testing
- What is being tested?
- Print Genetic Education Guide and Digital Guide Genetic Education Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2026to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Capable of providing informed consent
- Have internet access (via smartphone, tablet or computer)
- Comfortable using a computer or mobile phone independently to access information
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Rutgers University/Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Anita Kinney, PhD, 732-675-1937, anita.kinney@rutgers.edu
Anita Kinney, PhD
Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Prostate Cancer Patients, Hereditary Cancer, Genetic Testing
- Being tested
- Print Genetic Education Guide, Digital Guide Genetic Education Guide, Enhanced Usual Care
- Keywords
- Prostate cancer, survivorship, genetic counseling, genetic testing, hereditary cancer, Chatbot
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Print Genetic Education GuideBehavioural
Also called Print+
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 GuideBehavioural
Also called DG+
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 CareBehavioural
Also called EUC
Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Digital Guide Genetic Education Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1-Month and 6-Month surveys
Secondary outcomes (1)
Survey Assessment of Engagement with Genetic Education
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.
Measured: 1-Month Survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jul 2029 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers University
- Responsible party
- Principal investigator, Marc D Schwartz, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618520
- Sponsor's protocol ID
- 25-08-272
- Other IDs
- R01CA296911
- Acronym
- ENGAGE
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Genetic Access and Guided Education for Prostate Cancer Survivors
- ClinicalTrials.gov ID
- NCT07618520
- Acronym / sponsor ID
- ENGAGE / 25-08-272
- Conditions
- Prostate Cancer Patients, Hereditary Cancer, Genetic Testing
- Keywords
- Prostate cancer, survivorship, genetic counseling, genetic testing, hereditary cancer, Chatbot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual CareParticipants 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. |
| Print Genetic Education plus Streamlined Genetic Testing (Print+) | Experimental | Behavioral: Print Genetic Education GuideParticipants 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. |
| Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+) | Experimental | Behavioral: Digital Guide Genetic Education GuideParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Print Genetic Education GuideAlso: Print+Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk. | Behavioural | Print Genetic Education plus Streamlined Genetic Testing (Print+) |
| Digital Guide Genetic Education GuideAlso: DG+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. | Behavioural | Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+) |
| Enhanced Usual CareAlso: EUCConsists of clinical letter and recommendation/referral to schedule a genetic counseling session. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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.
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.
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.
1 secondary outcome
Survey Assessment of Engagement with Genetic Education
Time frame: 1-Month Survey
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Print Genetic Education Guide and Digital Guide Genetic Education Guide in people with Prostate Cancer Patients and Hereditary Cancer, run by Georgetown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Schwartz (202-687-0185, schwartm@georgetown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of Germline Genetic Testing (time frame: 6-Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.