Prostate Cancer Education in African American Men
|ClinicalTrials.gov Identifier: NCT01415375|
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Screening Decision||Behavioral: Prostate Cancer Screening Education Behavioral: Fruit and Vegetable Intake Education||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||490 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Prostate Cancer Education in African American Men|
|Study Start Date :||September 2004|
|Primary Completion Date :||July 2007|
|Study Completion Date :||July 2009|
Experimental: Prostate Cancer Screening Education
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
tailored telephone education on prostate cancer testing
Fruit and Vegetable Intake Education
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
tailored telephone education about fruit and vegetable consumption
- congruence between prostate cancer testing intention and behavior [ Time Frame: 1 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).
- Knowledge about prostate cancer and prostate cancer tests [ Time Frame: baseline 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 conflict [ Time Frame: 8 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 testing [ Time Frame: 2 years post randomization ]Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records
- State anxiety [ Time Frame: baseline and 8 months post-randomization ]Used a 7 item subscale of the Hospital Anxiety and Depression Scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415375
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19122|
|Principal Investigator:||Stephen Lepore, PhD||Temple University|