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

Not Applicable

Completed

• Conditions: Prostate Cancer Screening
• Interventions: Other: PSA flyer

• Registration Number: NCT01516801
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-01
• Study First Submitted: 2012-01-10
• Study First Submitted QC: 2012-01-24
• Last Update Submitted: 2012-01-24
• Study First Posted: 2012-01-25
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 303

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

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Exclusion Criteria

• active cancer diagnosis
• history of prostate cancer
• need for PSA surveillance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSA flyer	PSA flyer	-

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
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.
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.
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

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States