Prostate Cancer Education in African American Men

Prostate Cancer Screening Decision Clinical Trial

Official title:

Prostate Cancer Education in African American Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415375
• Other study ID #: R01CA104223
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 10, 2011
• Last updated: April 16, 2015
• Start date: September 2004
• Est. completion date: July 2009

Study information

• Verified date: April 2015
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: July 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer Screening Decision
• Prostatic Neoplasms

Intervention

Behavioral:
• Prostate Cancer Screening Education
tailored telephone education on prostate cancer testing
• Fruit and Vegetable Intake Education
tailored telephone education about fruit and vegetable consumption

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	congruence between prostate cancer testing intention and behavior	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	No
Primary	Knowledge about prostate cancer and prostate cancer tests	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	No
Primary	Decisional conflict	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	No
Primary	Verified doctor visit to discuss prostate cancer testing	Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records	2 years post randomization	No
Secondary	State anxiety	Used a 7 item subscale of the Hospital Anxiety and Depression Scale.	baseline and 8 months post-randomization	Yes