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

Prostate Clinical Trial

Official title:

A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03197896
• Other study ID #: 15G.337
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 29, 2016
• Est. completion date: May 1, 2021

Study information

• Verified date: January 2020
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 prostate cancer screening.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 296
• Est. completion date: May 1, 2021
• Est. primary completion date: January 4, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate
• Prostatic Neoplasms

Intervention

Other:
• Educational Intervention
Review prostate cancer information

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Themes identified by focus group transcripts	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.	Up to 4 years
Primary	Change in prostate cancer knowledge as measured by a 17-item scale	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.	Baseline to up to 4 months

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital