NCT01415375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

August 10, 2011

Last Update Submit

April 16, 2015

Conditions

Prostate Cancer Screening Decision

Keywords

prostate-specific antigen (146-154)prostate-specific antigen (154-163)

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (1)

  • State anxiety

    baseline and 8 months post-randomization

Study Arms (2)

Prostate Cancer Screening Education

EXPERIMENTAL

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

Fruit and Vegetable Intake Education

OTHER

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

Interventions

Prostate Cancer Screening EducationBEHAVIORAL

tailored telephone education on prostate cancer testing

Prostate Cancer Screening Education
Fruit and Vegetable Intake EducationBEHAVIORAL

tailored telephone education about fruit and vegetable consumption

Fruit and Vegetable Intake Education

Eligibility Criteria

Age45 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 70 year old
  • African descent
  • accessible by telephone
  • have primary care physician

You may not qualify if:

  • Prostate cancer test in 12 months prior to enrollment
  • History of prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Related 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.

    PMID: 22825933BACKGROUND

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stephen Lepore, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

September 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2009

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(1)