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

Primary Purpose

Prostate

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (prostate cancer information)

Group II (general health information)

Arm Description

The educator reviews general information about the prostate Cancer

The educator reviews topics about health promotion actions.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2017
Last Updated
January 15, 2020
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03197896
Brief Title
Educational Intervention in Increasing Knowledge About Prostate Cancer in High-Risk Neighborhoods
Official Title
A Neighborhood-Based Intervention to Reduce Prostate Cancer Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2016 (Actual)
Primary Completion Date
January 4, 2019 (Actual)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (prostate cancer information)
Arm Type
Experimental
Arm Description
The educator reviews general information about the prostate Cancer
Arm Title
Group II (general health information)
Arm Type
Active Comparator
Arm Description
The educator reviews topics about health promotion actions.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Intervention Description
Review prostate cancer information
Primary Outcome Measure Information:
Title
Themes identified by focus group transcripts
Description
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.
Time Frame
Up to 4 years
Title
Change in prostate cancer knowledge as measured by a 17-item scale
Description
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.
Time Frame
Baseline to up to 4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charnita Zeigler-Johnson, MPH, PhD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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