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
  Purpose

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


Condition Intervention Phase
Prostate Cancer Screening Decision
Behavioral: Prostate Cancer Testing Education
Behavioral: Fruit and Vegetable Education
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Prostate Cancer Education in African American Men

Resource links provided by NLM:


Further study details as provided by Temple University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 490
Study Start Date: September 2004
Study Completion Date: July 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Prostate Cancer Testing 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 Education
tailored telephone education about fruit and vegetable consumption

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).

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415375

Locations
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19122
Sponsors and Collaborators
Temple University
Investigators
Principal Investigator: Stephen Lepore, PhD Temple University
  More Information

No publications provided

Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01415375     History of Changes
Other Study ID Numbers: R01CA104223
Study First Received: August 10, 2011
Last Updated: August 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Temple University:
prostate-specific antigen (146-154)
prostate-specific antigen (154-163)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014