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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937585
• Other study ID #: CTMHB-DOD
• Secondary ID: W81XWH-06-1-0099
• Status: Completed
• Phase: N/A
• First received: August 30, 2013
• Last updated: September 7, 2013
• Start date: August 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).
• 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

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	Knowledge Networks

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sajid S, Kotwal AA, Dale W. Interventions to improve decision making and reduce racial and ethnic disparities in the management of prostate cancer: a systematic review. J Gen Intern Med. 2012 Aug;27(8):1068-78. doi: 10.1007/s11606-012-2086-5. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partner-reported actions of mate to initiate a provider visit to discuss prostate cancer screening		Two weeks post baseline	No