Prostate Cancer Education in African American Men

NCT ID: NCT01415375

Last Updated: 2015-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

490 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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).

Conditions

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Prostate Cancer Screening Decision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Prostate Cancer Screening Education

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Fruit and Vegetable Intake Education

Intervention Type BEHAVIORAL

tailored telephone education about fruit and vegetable consumption

Interventions

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Prostate Cancer Screening Education

tailored telephone education on prostate cancer testing

Intervention Type BEHAVIORAL

Fruit and Vegetable Intake Education

tailored telephone education about fruit and vegetable consumption

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Lepore, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

Locations

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Temple University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Lepore SJ, Wolf RL, Basch CE, Godfrey M, McGinty E, Shmukler C, Ullman R, Thomas N, Weinrich S. Informed decision making about prostate cancer testing in predominantly immigrant black men: a randomized controlled trial. Ann Behav Med. 2012 Dec;44(3):320-30. doi: 10.1007/s12160-012-9392-3.

Reference Type BACKGROUND
PMID: 22825933 (View on PubMed)

Other Identifiers

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R01CA104223

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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