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Prostate Cancer Education in African American Men

Phase 2
Completed
Conditions
Prostate Cancer Screening Decision
Interventions
Behavioral: Fruit and Vegetable Intake Education
Behavioral: Prostate Cancer Screening Education
Registration Number
NCT01415375
Lead Sponsor
Temple University
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
490
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Fruit and Vegetable Intake EducationFruit and Vegetable Intake EducationMen 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.
Prostate Cancer Screening EducationProstate Cancer Screening EducationMen 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.
Primary Outcome Measures
NameTimeMethod
Knowledge about prostate cancer and prostate cancer testsbaseline and 8 months post randomization

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 conflict8 months post randomization

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 testing2 years post randomization

Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records

congruence between prostate cancer testing intention and behavior1 and 2 years post randomization

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).

Secondary Outcome Measures
NameTimeMethod
State anxietybaseline and 8 months post-randomization

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

Trial Locations

Locations (1)

Temple University

🇺🇸

Philadelphia, Pennsylvania, United States

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