- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197896
Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods
A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities
Study Overview
Detailed Description
PRIMARY OBJECTIVES:
I. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Sidney Kimmel Cancer Center at Thomas Jefferson University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
• 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (prostate cancer information)
The educator reviews general information about the prostate Cancer
|
Review prostate cancer information
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Active Comparator: Group II (general health information)
The educator reviews topics about health promotion actions.
|
Review prostate cancer information
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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."
|
4 months
|
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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.
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baseline to 4 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Charnita Zeigler-Johnson, MPH, PhD, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15G.337
- JT 7860 (Other Identifier: JeffTrial Number)
- PC140667 (Other Grant/Funding Number: Department of Defense)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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