Trial of Print Messages to Support the Role of Partners in Promoting Provider Discussions About Prostate Cancer Screening Among AA Men

September 7, 2013 updated by: Fox Chase Cancer Center

Evaluation of a Culturally Targeted, Personalized Mail-Home Brochure Directed to Partners of At-Risk Men to Facilitate Prostate Cancer Risk Assessment

The purpose of this study is to determine whether female partners of African American men can promote initiation of a discussion with a healthcare provider about prostate cancer screening when the partner is supported by a print message designed to provide relevant information and strategies for her to use in this effort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: Although AA men are at elevated risk for prostate cancer (Pca), medical guidelines do not present consistent screening recommendations for this group. However, all guidelines stress the need for screening decision making with a provider. This study evaluated the effectiveness of a brochure designed for the female partners of AA men, designed to help promote such discussion on the part of their mates. We also explored the effect of the partner's monitoring style (i.e., the extent to which the partner typically attends to health threats) on promoting discussion.

Methods: Female partners of AA men (N=231) were randomized to receive either a Pca screening CDC brochure for AA men, combined with a "partner" brochure containing strategies to promote men's initiation of a provider visit to discuss screening, or the CDC brochure only, and completed pre- and post-intervention surveys online.

Conclusions: High monitoring partners may be effective in influencing their AA mates to initiate provider discussion, particularly when tailored messaging is provided.

Study Type

Interventional

Enrollment (Actual)

231

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • U.S. female aged 18 and over, and having an AA male partner between the ages of 35 and 69 with no history of a Pca diagnosis

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CDC brochure only condition
Receipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer
Behavioral: CDC brochure only condition
Receipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer
Experimental: Partner and CDC brochure condition
Receipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening).
Behavioral: Partner and CDC brochure condition
Receipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Partner-reported actions of mate to initiate a provider visit to discuss prostate cancer screening
Time Frame: Two weeks post baseline
Two weeks post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

Knowledge Networks

Investigators

  • Principal Investigator: Suzanne M Miller, PhD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

September 7, 2013

First Posted (Estimate)

September 9, 2013

Study Record Updates

Last Update Posted (Estimate)

September 9, 2013

Last Update Submitted That Met QC Criteria

September 7, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTMHB-DOD
  • W81XWH-06-1-0099 (Other Grant/Funding Number: Department of Defense)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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