Prostate Cancer Education in African American Men

April 16, 2015 updated by: Temple University
This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

490

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
        • Temple University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 and 2 years post randomization
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.
baseline and 8 months post randomization
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.
8 months post randomization
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
2 years post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State anxiety
Time Frame: baseline and 8 months post-randomization
Used a 7 item subscale of the Hospital Anxiety and Depression Scale.
baseline and 8 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Temple University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01CA104223 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer Screening Decision

Clinical Trials on Prostate Cancer Screening Education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe