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

Not Applicable

• Conditions: Prostate
• Interventions: Other: Educational Intervention

• Registration Number: NCT03197896
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief 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 prostate cancer screening.

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 Timeline

• Study Start: 2016-09-29
• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-23
• Primary Completion: 2019-01-04
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-15
• Last Update Posted: 2020-01-18
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 296

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (general health information)	Educational Intervention	The educator reviews topics about health promotion actions.
Group I (prostate cancer information)	Educational Intervention	The educator reviews general information about the prostate Cancer

Primary Outcome Measures

Name	Time	Method
Change in prostate cancer knowledge as measured by a 17-item scale	Baseline to up to 4 months	Descriptive analyses will be used including t-test, frequency tables, nonparametric tests, correlations, regression models. Linear and generalized linear mixed models having random intercepts corresponding to neighborhood will be applied.
Themes identified by focus group transcripts	Up to 4 years	Focus group transcripts will be analyzed by iterative rounds of coding by at least two members of the research team. Specific themes and trends will be identified within each transcript and discussed by the research team until final consensus is reached. Themes will be identified as topics that consistently occur across transcripts, as well as similarities and differences between transcripts.

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States