A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT01516801
Collaborator
(none)
303
1
2
10
30.3

Study Details

Study Description

Brief Summary

  1. Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?

  2. Do patients find the flyer useful and understandable?

Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.

Condition or Disease Intervention/Treatment Phase
  • Other: PSA flyer
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: PSA flyer

Other: PSA flyer
A mailed low-literacy informational patient flyer about the PSA test

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Rate of PSA testing [At the time of the annual exam (within two weeks of their annual physical)]

    Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical

  2. Rate of documented PSA discussions [At the time of the annual exam (within two weeks of their annual physical)]

    Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.

Secondary Outcome Measures

  1. Flyer acceptability [Within two weeks of the annual exam]

    The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.

  2. Perceived participation [Within two weeks]

    Perceived participation will be assessed in a follow-up phone interview within two weeks of the annual physical using validated measures of particiption in decision making.

  3. Prostate Cancer Screening knowledge [Within two weeks]

    Prostate cancer screening knowledge will be assessed using 5 knowledge questions surrounding PSA testing during a follow-up interview 2 weeks after the annual physical

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 74 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Men age 50-74 who were cared for in a general internal medicine clinic

  • had scheduled an annual health exam

  • had not had a PSA test within the previous year

Exclusion Criteria:
  • active cancer diagnosis

  • history of prostate cancer

  • need for PSA surveillance

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Colorado Hospital Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01516801
Other Study ID Numbers:
  • 10-0603
First Posted:
Jan 25, 2012
Last Update Posted:
Jan 25, 2012
Last Verified:
Jan 1, 2012
Keywords provided by University of Colorado, Denver
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2012