Skip to content

Prostate Cancer Education in African American Men

Prostate Cancer Education in African American Men

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01415375
Enrollment
490
Registered
2011-08-11
Start date
2004-09-30
Completion date
2009-07-31
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Screening Decision

Keywords

prostate-specific antigen (146-154), prostate-specific antigen (154-163)

Brief summary

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

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).

Interventions

tailored telephone education on prostate cancer testing

BEHAVIORALFruit and Vegetable Intake Education

tailored telephone education about fruit and vegetable consumption

Sponsors

Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
45 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
congruence between prostate cancer testing intention and behavior1 and 2 years post randomizationCongruence 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 testsbaseline and 8 months post randomization12 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 conflict8 months post randomizationUsed 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 testing2 years post randomizationVisit with physician to talk about prostate cancer testing, with visit verified through medical claims records

Secondary

MeasureTime frameDescription
State anxietybaseline and 8 months post-randomizationUsed a 7 item subscale of the Hospital Anxiety and Depression Scale.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026