Healthy SubjectNCT05011799
The Peer Genetic Study
A study testing Cancer Educational Materials, Questionnaire Administration and Educational Intervention in people with Healthy Subject and Prostate Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Read more about this study
- Who is it for?
- Ages 35 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Prostate Carcinoma
- What is being tested?
- Cancer Educational Materials, Questionnaire Administration and Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2020to 28 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to read and speak English comfortably
- With or without a personal or family history of PCA
- Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate
Who cannot join
- Do not read or speak English comfortably
- Men who participated in a focus group will be excluded from participating in the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study
This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.
- Conditions
- Healthy Subject, Prostate Carcinoma
- Being tested
- Cancer Educational Materials, Questionnaire Administration, Educational Intervention
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Educational MaterialsBehavioural
Receive prostate cancer educational materials
Questionnaire AdministrationOther
Ancillary studies
Educational InterventionOther
Attend peer-led education sessions
| Study group | Role | What they receive |
|---|---|---|
| Arm I (health education) | Experimental | Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months. Receives: Other: Questionnaire Administration; Other: Educational Intervention |
| Arm II (cancer educational materials) | Active comparator | Participants receive mailed informational materials about PCA risk, family history, and genetic testing. Receives: Behavioral: Cancer Educational Materials; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in of decisional conflict
Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test.
Measured: Baseline up to 2 months
Awareness of risks and benefits of genetic testing
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects.
Measured: Up to 2 months post study
Perceptions of genetic testing
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Measured: Up to 2 months post study
Genetic testing
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Measured: Up to 2 months post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start8 Jan 2020
- Primary completion30 Jun 2023
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011799
- Sponsor's protocol ID
- 19F.496
- Other IDs
- W81XWH1910399, JT 14300
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2021
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study
- ClinicalTrials.gov ID
- NCT05011799
- Acronym / sponsor ID
- 19F.496
- Conditions
- Healthy Subject, Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 18 Aug 2021 (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.
This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (health education) | Experimental | Other: Questionnaire Administration, Other: Educational InterventionParticipants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months. |
| Arm II (cancer educational materials) | Active comparator | Behavioral: Cancer Educational Materials, Other: Questionnaire AdministrationParticipants receive mailed informational materials about PCA risk, family history, and genetic testing. |
Who may qualify
- Ages
- 35 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to read and speak English comfortably
- With or without a personal or family history of PCA
- Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate
Key exclusion criteria (2 listed)
- Do not read or speak English comfortably
- Men who participated in a focus group will be excluded from participating in the intervention
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 |
|---|---|---|
| Cancer Educational MaterialsReceive prostate cancer educational materials | Behavioural | Arm II (cancer educational materials) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (health education), Arm II (cancer educational materials) |
| Educational InterventionAttend peer-led education sessions | Other | Arm I (health education) |
Primary outcome
Change in of decisional conflict
Time frame: Baseline up to 2 months
Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test.
Awareness of risks and benefits of genetic testing
Time frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects.
Perceptions of genetic testing
Time frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Genetic testing
Time frame: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Educational Materials, Questionnaire Administration and Educational Intervention in people with Healthy Subject and Prostate Carcinoma, run by Thomas Jefferson University at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in of decisional conflict (time frame: Baseline up to 2 months). The study lists 4 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 27 Jan 2026.