Prostate Cancer Education in African American Men

Study Overview
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Brief Summary
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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
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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).

Official Title
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Prostate Cancer Education in African American Men

Conditions
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Prostate Cancer Screening Decision

Intervention / Treatment
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* Behavioral: Prostate Cancer Screening Education
* Behavioral: Fruit and Vegetable Intake Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate Cancer Screening Education<br>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. | Behavioral: Prostate Cancer Screening Education<br>* tailored telephone education on prostate cancer testing<br>|
| Other: Fruit and Vegetable Intake Education<br>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. | Behavioral: Fruit and Vegetable Intake Education<br>* tailored telephone education about fruit and vegetable consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 and 2 years post randomization | 
| 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. | baseline and 8 months post randomization | 
| Decisional conflict | Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations. | 8 months post randomization | 
| Verified doctor visit to discuss prostate cancer testing | Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records | 2 years post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State anxiety | Used a 7 item subscale of the Hospital Anxiety and Depression Scale. | baseline and 8 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate-specific antigen (146-154), prostate-specific antigen (154-163)