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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01516801
First received: January 10, 2012
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  Purpose
  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 Intervention
Prostate Cancer Screening
 Other: PSA flyer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Rate of PSA testing [ Time Frame: At the time of the annual exam (within two weeks of their annual physical) ] [ Designated as safety issue: No ]
    Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical

  • Rate of documented PSA discussions [ Time Frame: At the time of the annual exam (within two weeks of their annual physical) ] [ Designated as safety issue: No ]
    Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.


Secondary Outcome Measures:
  • Flyer acceptability [ Time Frame: Within two weeks of the annual exam ] [ Designated as safety issue: No ]
    The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.

  • Perceived participation [ Time Frame: Within two weeks ] [ Designated as safety issue: No ]
    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.

  • Prostate Cancer Screening knowledge [ Time Frame: Within two weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 303
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PSA flyer Other: PSA flyer
A mailed low-literacy informational patient flyer about the PSA test
No Intervention: Control

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516801

Locations
United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01516801     History of Changes
Other Study ID Numbers: 10-0603
Study First Received: January 10, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Prostate Cancer Screening
Pragmatic Trial
Health Literacy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013