NCT01415375|CompletedPhase 2/3DMC
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Sponsor study identifier
NIH
interventional
490
1 country
1
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2007
Actual (reported)Study Completion
July 2009
Actual (reported)This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
July 2007
Actual (reported)July 2009
Actual (reported)August 10, 2011
Actual (reported)August 11, 2011
Actual (reported)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
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
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
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
State anxiety
baseline and 8 months post-randomization
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.
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.
tailored telephone education on prostate cancer testing
tailored telephone education about fruit and vegetable consumption
Temple University
Philadelphia, Pennsylvania, 19122, United States
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.
Stephen Lepore, PhD
Temple University
490 participants (actual enrollment reported by the registry).
First Submitted
August 10, 2011
First Posted
August 11, 2011
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2007
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
April 17, 2015
Record last verified: 2015-04
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Source: ClinicalTrials.gov.
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