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Completed

NCT Number: NCT01415375

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.

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Key information

Conditions

Prostate Cancer Screening Decision

Age range

45 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Temple University

Philadelphia, Pennsylvania, 19122, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate Cancer Screening Education

Behavioral

tailored telephone education on prostate cancer testing

Fruit and Vegetable Intake Education

Behavioral

tailored telephone education about fruit and vegetable consumption

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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

Secondary outcomes

  1. State anxiety

    Time frame: baseline and 8 months post-randomization

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

Sponsors and collaborators

Lead sponsor

Temple University

Other

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Aug 11, 2011
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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