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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01516801
Enrollment
303
Registered
2012-01-25
Start date
2009-10-31
Completion date
2010-08-31
Last updated
2012-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Screening

Keywords

Prostate Cancer Screening, Pragmatic Trial, Health Literacy

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.

Interventions

OTHERPSA flyer

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

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 74 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Rate of PSA testingAt 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 discussionsAt 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

MeasureTime frameDescription
Flyer acceptabilityWithin two weeks of the annual examThe acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.
Perceived participationWithin two weeksPerceived 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 knowledgeWithin two weeksProstate cancer screening knowledge will be assessed using 5 knowledge questions surrounding PSA testing during a follow-up interview 2 weeks after the annual physical

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026