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Prostate Cancer Education in African American Men

Primary Purpose

Prostate Cancer Screening Decision

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Prostate Cancer Screening Education
Fruit and Vegetable Intake Education
Sponsored by
Temple University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer Screening Decision focused on measuring prostate-specific antigen (146-154), prostate-specific antigen (154-163)

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 45 to 70 year old
  • African descent
  • accessible by telephone
  • have primary care physician

Exclusion Criteria:

  • Prostate cancer test in 12 months prior to enrollment
  • History of prostate cancer

Sites / Locations

  • Temple University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prostate Cancer Screening Education

Fruit and Vegetable Intake Education

Arm Description

Men in the experimental intervention group received an educational pamphlet on prostate cancer testing as well as tailored telephone education in which the interventionist provided information, answered questions, and conducted a values clarification exercise with the participant.

Men in the attention control group received an educational pamphlet on daily recommended servings of fruits and vegetables as well as tailored telephone education in which the interventionist provided information, answered participant's questions, and discussed any barriers to eating fruits and vegetables.

Outcomes

Primary Outcome Measures

congruence between prostate cancer testing intention and behavior
Congruence between men's stated intentions to get tested and their actual testing behavior, validated by medical claims at 1 and 2 year follow-up. Intention-behavior agreement was coded as congruent (1), whereas disagreement was coded as incongruent (0).
Knowledge about prostate cancer and prostate cancer tests
12 item knowledge index with questions on testing, risk factors and epidemiology, and treatment effectiveness and side effects. Percent correct was used as the outcome measure.
Decisional conflict
Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations.
Verified doctor visit to discuss prostate cancer testing
Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records

Secondary Outcome Measures

State anxiety
Used a 7 item subscale of the Hospital Anxiety and Depression Scale.

Full Information

First Posted
August 10, 2011
Last Updated
April 16, 2015
Sponsor
Temple University
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1. Study Identification

Unique Protocol Identification Number
NCT01415375
Brief Title
Prostate Cancer Education in African American Men
Official Title
Prostate Cancer Education in African American Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.
Detailed Description
African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer Screening Decision
Keywords
prostate-specific antigen (146-154), prostate-specific antigen (154-163)

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
490 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate Cancer Screening Education
Arm Type
Experimental
Arm Description
Men in the experimental intervention group received an educational pamphlet on prostate cancer testing as well as tailored telephone education in which the interventionist provided information, answered questions, and conducted a values clarification exercise with the participant.
Arm Title
Fruit and Vegetable Intake Education
Arm Type
Other
Arm Description
Men in the attention control group received an educational pamphlet on daily recommended servings of fruits and vegetables as well as tailored telephone education in which the interventionist provided information, answered participant's questions, and discussed any barriers to eating fruits and vegetables.
Intervention Type
Behavioral
Intervention Name(s)
Prostate Cancer Screening Education
Intervention Description
tailored telephone education on prostate cancer testing
Intervention Type
Behavioral
Intervention Name(s)
Fruit and Vegetable Intake Education
Intervention Description
tailored telephone education about fruit and vegetable consumption
Primary Outcome Measure Information:
Title
congruence between prostate cancer testing intention and behavior
Description
Congruence between men's stated intentions to get tested and their actual testing behavior, validated by medical claims at 1 and 2 year follow-up. Intention-behavior agreement was coded as congruent (1), whereas disagreement was coded as incongruent (0).
Time Frame
1 and 2 years post randomization
Title
Knowledge about prostate cancer and prostate cancer tests
Description
12 item knowledge index with questions on testing, risk factors and epidemiology, and treatment effectiveness and side effects. Percent correct was used as the outcome measure.
Time Frame
baseline and 8 months post randomization
Title
Decisional conflict
Description
Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations.
Time Frame
8 months post randomization
Title
Verified doctor visit to discuss prostate cancer testing
Description
Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records
Time Frame
2 years post randomization
Secondary Outcome Measure Information:
Title
State anxiety
Description
Used a 7 item subscale of the Hospital Anxiety and Depression Scale.
Time Frame
baseline and 8 months post-randomization

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 45 to 70 year old African descent accessible by telephone have primary care physician Exclusion Criteria: Prostate cancer test in 12 months prior to enrollment History of prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Lepore, PhD
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22825933
Citation
Lepore SJ, Wolf RL, Basch CE, Godfrey M, McGinty E, Shmukler C, Ullman R, Thomas N, Weinrich S. Informed decision making about prostate cancer testing in predominantly immigrant black men: a randomized controlled trial. Ann Behav Med. 2012 Dec;44(3):320-30. doi: 10.1007/s12160-012-9392-3.
Results Reference
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Prostate Cancer Education in African American Men

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