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

Prostate Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516801
• Other study ID #: 10-0603
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: January 24, 2012
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 74 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer Screening
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PSA testing	Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical	At the time of the annual exam (within two weeks of their annual physical)	No
Primary	Rate of documented PSA discussions	Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.	At the time of the annual exam (within two weeks of their annual physical)	No
Secondary	Flyer acceptability	The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.	Within two weeks of the annual exam	No
Secondary	Perceived participation	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.	Within two weeks	No
Secondary	Prostate Cancer Screening knowledge	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	Within two weeks	No