Prostate Cancer Education in African American Men

Prostate Cancer Education in African American Men

Sponsors

Lead Sponsor: Temple University

Source Temple University
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).

Overall Status Completed
Start Date September 2004
Completion Date July 2009
Primary Completion Date July 2007
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
congruence between prostate cancer testing intention and behavior 1 and 2 years post randomization
Knowledge about prostate cancer and prostate cancer tests baseline and 8 months post randomization
Decisional conflict 8 months post randomization
Verified doctor visit to discuss prostate cancer testing 2 years post randomization
Secondary Outcome
Measure Time Frame
State anxiety baseline and 8 months post-randomization
Enrollment 490
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Prostate Cancer Screening Education

Description: tailored telephone education on prostate cancer testing

Arm Group Label: Prostate Cancer Screening Education

Intervention Type: Behavioral

Intervention Name: Fruit and Vegetable Intake Education

Description: tailored telephone education about fruit and vegetable consumption

Arm Group Label: Fruit and Vegetable Intake Education

Eligibility

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

Gender: Male

Minimum Age: 45 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Stephen Lepore, PhD Principal Investigator Temple University
Location
Facility: Temple University
Location Countries

United States

Verification Date

April 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Prostate Cancer Screening Education

Type: Experimental

Description: 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.

Label: Fruit and Vegetable Intake Education

Type: Other

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Screening

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov