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OpenTrials
Completed

NCT Number: NCT01516801

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

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.

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Key information

Age range

50 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSA flyer

Other

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

Primary outcomes

  1. Rate of PSA testing

    Time frame: 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

    Time frame: 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 outcomes

  1. Flyer acceptability

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2012
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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