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Prostate Cancer Education in African American Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Temple University
ClinicalTrials.gov Identifier:
NCT01415375
First received: August 10, 2011
Last updated: August 23, 2011
Last verified: August 2011
History of Changes

August 10, 2011
August 23, 2011
September 2004
July 2007   (final data collection date for primary outcome measure)
  • congruence between prostate cancer testing intention and behavior [ Time Frame: 1 and 2 years post randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records
Same as current
Complete list of historical versions of study NCT01415375 on ClinicalTrials.gov Archive Site
State anxiety [ Time Frame: baseline and 8 months post-randomization ] [ Designated as safety issue: Yes ]
Used a 7 item subscale of the Hospital Anxiety and Depression Scale.
State anxiety [ Time Frame: baseline and 8 months post-randomization ] [ Designated as safety issue: No ]
Used a 7 item subscale of the Hospital Anxiety and Depression Scale.
Not Provided
Not Provided
 
Prostate Cancer Education in African American Men
Prostate Cancer Education in African American Men

This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.

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).
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Prostate Cancer Screening Decision
  • Behavioral: Prostate Cancer Testing Education
    tailored telephone education on prostate cancer testing
  • Behavioral: Fruit and Vegetable Education
    tailored telephone education about fruit and vegetable consumption
  • Experimental: Prostate Cancer 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.
    Intervention: Behavioral: Prostate Cancer Testing Education
  • 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.
    Intervention: Behavioral: Fruit and Vegetable Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
490
July 2009
July 2007   (final data collection date for primary outcome measure)

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
Male
45 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01415375
R01CA104223
Yes
Temple University
Temple University
Not Provided
Principal Investigator: Stephen Lepore, PhD Temple University
Temple University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP