ProstateNCT03197896

Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods

A study testing Educational Intervention in people with Prostate, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This clinical trial studies how well an educational intervention works in increasing knowledge about prostate cancer in high-risk neighborhoods. Learning about prostate cancer and the pros and cons of screening for prostate cancer may increase knowledge about prostate cancer while decreasing anxiety and concerns about… Read more about this study

Who is it for?: Ages 40 to 69 years, men only
Conditions the study is for: Prostate
What is being tested?: Educational Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 239 participants
Where: 1 siteUnited States
Study dates: 29 Sep 2016to 20 Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 69 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Focus groups consisting of men who live, work, or worship in the 4 predetermined neighborhoods
Currently reside in one of the four selected high risk neighborhoods

Who cannot join

Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen [PSA] or digital rectal examination [DRE]) within the past 12 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities

Read the detailed description

PRIMARY OBJECTIVES:

To identify neighborhoods with disproportionately high rates of advanced prostate cancer and describe patient- and neighborhood-level risk factors associated with the high-risk neighborhoods.

II. To develop, using a mixed methods approach, a targeted educational intervention about prostate cancer for men who live in high risk neighborhoods.

III. To test the impact of the targeted intervention on levels of knowledge, anxiety, and informed decision making about prostate cancer (PCa) screening.

IV. To observe the rates of PCa screening in the intervention and control groups.

Conditions: Prostate
Being tested: Educational Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Educational InterventionOther
Review prostate cancer information

Study groups in NCT03197896
Study group	Role	What they receive
Group I (prostate cancer information)	Experimental	The educator reviews general information about the prostate Cancer Receives: Other: Educational Intervention
Group II (general health information)	Active comparator	The educator reviews topics about health promotion actions. Receives: Other: Educational Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale
The Decisional Conflict Scale (DCS) measures uncertainty in health decision-making. It includes 16 items rated on a 5-point Likert scale. Scores are calculated by averaging item responses and multiplying by 25, yielding a range from 0 (no conflict) to 100 (high conflict). Lower scores indicate greater clarity, confidence, and satisfaction with the decision. Higher scores reflect uncertainty, lack of information/support, and low confidence. The self-efficacy subscale assesses confidence in decision-making with responses like "a lot confident," "a little confident," or "not at all confident."
Measured: 4 months
Intent to Screen for PCa
Estimated mean changes from baseline assessment in likelihood of screening by study group from baseline to 4 month follow up. Intent to screen for prostate cancer was measured on a 5 point Likert Scale (1= very unlikely to 5=very likely). Results represent estimated mean change and 95% Confidence Interval from baseline in intent-to-screen score.
Measured: baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Sep 201620 Jul 2018

First posted23 Jun 2017
Study start29 Sep 2016
Primary completion20 Jul 2018
Study completion20 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ProstateStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03197896
Sponsor's protocol ID: 15G.337
Other IDs: JT 7860, PC140667
Status last verified: Mar 2026
First submitted: 22 Jun 2017
Last updated: 25 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms

All Prostate trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities
ClinicalTrials.gov ID: NCT03197896
Acronym / sponsor ID: 15G.337
Conditions: Prostate
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: 29 Sep 2016 (actual)
Primary completion: 20 Jul 2018 (actual)
Study completion: 20 Jul 2018 (actual)
First posted: 23 Jun 2017 (actual)
Results: Posted 25 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To identify neighborhoods with disproportionately high rates of advanced prostate cancer and describe patient- and neighborhood-level risk factors associated with the high-risk neighborhoods.

II. To develop, using a mixed methods approach, a targeted educational intervention about prostate cancer for men who live in high risk neighborhoods.

III. To test the impact of the targeted intervention on levels of knowledge, anxiety, and informed decision making about prostate cancer (PCa) screening.

IV. To observe the rates of PCa screening in the intervention and control groups.

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group I (prostate cancer information)	Experimental	Other: Educational InterventionThe educator reviews general information about the prostate Cancer
Group II (general health information)	Active comparator	Other: Educational InterventionThe educator reviews topics about health promotion actions.

Who may qualify

Ages: 40 to 69 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Focus groups consisting of men who live, work, or worship in the 4 predetermined neighborhoods
Currently reside in one of the four selected high risk neighborhoods

Key exclusion criteria (1 listed)

Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen [PSA] or digital rectal examination [DRE]) within the past 12 months

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
Educational InterventionReview prostate cancer information	Other	Group I (prostate cancer information), Group II (general health information)

Primary outcome

Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale
Time frame: 4 months
The Decisional Conflict Scale (DCS) measures uncertainty in health decision-making. It includes 16 items rated on a 5-point Likert scale. Scores are calculated by averaging item responses and multiplying by 25, yielding a range from 0 (no conflict) to 100 (high conflict). Lower scores indicate greater clarity, confidence, and satisfaction with the decision. Higher scores reflect uncertainty, lack of information/support, and low confidence. The self-efficacy subscale assesses confidence in decision-making with responses like "a lot confident," "a little confident," or "not at all confident."
Intent to Screen for PCa
Time frame: baseline to 4 months
Estimated mean changes from baseline assessment in likelihood of screening by study group from baseline to 4 month follow up. Intent to screen for prostate cancer was measured on a 5 point Likert Scale (1= very unlikely to 5=very likely). Results represent estimated mean change and 95% Confidence Interval from baseline in intent-to-screen score.

Results and safety

Results posted to the registry on 25 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (Prostate Cancer Information)	121	121
Group II (General Health Information)	118	118

Primary outcome: Change in Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale

Time frame: 4 months. Median (Full Range). Unit: score on a scale

Measure	Group I (Prostate Cancer Information) n = 121	Group II (General Health Information) n = 118
Value	80 (40 to 100)	70 (40 to 100)

Primary outcome: Intent to Screen for PCa

Time frame: baseline to 4 months. Mean (95% Confidence Interval). Unit: Scores on a Scale (1-5)

Measure	Group I (Prostate Cancer Information) n = 121	Group II (General Health Information) n = 118
Value	0.91 (0.49 to 1.32)	0.78 (0.40 to 1.16)

Adverse events

Time frame: reporting for adverse events was done for participants during active participation and for 4 months following completion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (Prostate Cancer Information)	0 of 121 (0%)	0 of 121 (0%)	0 of 121
Group II (General Health Information)	0 of 118 (0%)	0 of 118 (0%)	0 of 118

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Sidney Kimmel Cancer CenterLink provided by the sponsor.
Thomas Jefferson University HospitalLink provided by the sponsor.

Related trials for Prostate

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
RecruitingObservational study
Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy
Prostatic Neoplasms, Prostate Cancer
RecruitingPhase 1
A Study of LY4257496 in Participants With Cancer (OMNIRAY)
Breast Neoplasms, Colorectal Neoplasms

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.

Charnita Zeigler-Johnson, MPH, PhD principal investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention in people with Prostate, run by Sidney Kimmel Comprehensive Cancer Center at 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 2 inclusion and 1 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 25 Mar 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?

Yes. Results are posted in the registry (first posted 25 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Prostate Cancer Knowledge as Measured by the Decisional Conflict Scale (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03197896.

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 25 Mar 2026.