NCT01516801

Brief Summary

  1. 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. 2.Do patients find the flyer useful and understandable?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

January 10, 2012

Last Update Submit

January 24, 2012

Conditions

Prostate Cancer Screening

Keywords

Prostate Cancer ScreeningPragmatic TrialHealth Literacy

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Secondary Outcomes (3)

  • Flyer acceptability

    Within two weeks of the annual exam

  • Perceived participation

    Within two weeks

  • Prostate Cancer Screening knowledge

    Within two weeks

Study Arms (2)

PSA flyer

EXPERIMENTAL
Other: PSA flyer

Control

NO INTERVENTION

Interventions

PSA flyerOTHER

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

PSA flyer

Eligibility Criteria

Age50 Years - 74 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 25, 2012

Study Start

October 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations

US(1)