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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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Prostate Cancer Screening

Treatments

Other: PSA flyer

Study type

Interventional

Funder types

Other

Identifiers

NCT01516801
10-0603 (Other Identifier)

Details and patient eligibility

About

  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.

Enrollment

303 patients

Sex

Male

Ages

50 to 74 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

303 participants in 2 patient groups

PSA flyer
Experimental group
Treatment:
Other: PSA flyer
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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