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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03197896
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Prostate Other: Educational Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : September 29, 2016
Actual Primary Completion Date : January 4, 2019
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. Themes identified by focus group transcripts [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197896


Locations
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United States, Pennsylvania
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
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Principal Investigator: Charnita Zeigler-Johnson, MPH, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03197896     History of Changes
Other Study ID Numbers: 15G.337
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases