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

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03197896
Collaborator
United States Department of Defense (U.S. Fed)
296
1
2
55
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Educational Intervention
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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.

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

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

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

Study Design

Study Type:
Interventional
Actual Enrollment :
296 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities
Actual Study Start Date :
Sep 29, 2016
Actual Primary Completion Date :
Jan 4, 2019
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (prostate cancer information)

The educator reviews general information about the prostate Cancer

Other: Educational Intervention
Review prostate cancer information

Active Comparator: Group II (general health information)

The educator reviews topics about health promotion actions.

Other: Educational Intervention
Review prostate cancer information

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 69 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University
  • United States Department of Defense

Investigators

  • Principal Investigator: Charnita Zeigler-Johnson, MPH, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT03197896
Other Study ID Numbers:
  • 15G.337
First Posted:
Jun 23, 2017
Last Update Posted:
Jan 18, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2020