NCT01937585

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2010

Shorter than P25 for not_applicable prostate-cancer

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

August 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

3 months

First QC Date

August 30, 2013

Last Update Submit

September 7, 2013

Conditions

Keywords

prostate cancerpartnercommunication messagesmonitoring styleAA men

Outcome Measures

Primary Outcomes (1)

  • Partner-reported actions of mate to initiate a provider visit to discuss prostate cancer screening

    Two weeks post baseline

Study Arms (2)

CDC brochure only condition

ACTIVE COMPARATOR

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

Partner and CDC brochure condition

EXPERIMENTAL

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

Interventions

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).

Partner and CDC brochure 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

CDC brochure only condition

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related 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.

    PMID: 22798216BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Suzanne M Miller, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 9, 2013

Study Start

August 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations