NCT01516801

Completed

A Pragmatic Trial of the Effect of a Mailed Patient Flyer Ab...

University of Colorado, Denver Source

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Other study identifiers

Sponsor study identifier

10-0603

Study Type

interventional

Actual enrollment (reported)

303

Locations

1 country

Sites

1

Timeline

Study Start

October 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2010

Actual (reported)

Study Completion

August 2010

Actual (reported)

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?

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 303 participants
Study completion date: August 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2009
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)
Study Completion
August 2010
Actual (reported)
First Submitted
January 10, 2012
Actual (reported)
First Posted
January 25, 2012
Actual (reported)

Last Updated: January 25, 2012
Status Verified: January 2012
Last Update Submitted: 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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

University of Colorado, Denver
Otherlead

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Enrollment

303 participants (actual enrollment reported by the registry).

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 2009

Date type not reported

This date has not been verified as actual or estimated.

Unknown

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Not ApplicableCompleted

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Screening for Prostate Cancer Using High Resolution Micro-ultrasound Versus Multiparametric Magnetic Resonance Imaging.

Phase 3Recruiting

NCT06923657

PSMA PET/MRI-Guided Prostate Biopsy for PI-RADS ≤3 and Prior Negative Biopsy

Not ApplicableRecruiting

NCT06678828

Clinical Utility of ClarityDX Prostate

Not ApplicableEnrolling By Invitation

NCT03957252

Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

Active Not Recruiting

NCT04601272

Evaluating the Shared Decision Making Process Scale in Cancer Screening Decisions

Completed

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.

Primary Completion

August 2010

Actual (reported)

Study Completion

August 2010

Actual (reported)

Last Updated

January 25, 2012

Record last verified: 2012-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01516801
Data provider: ClinicalTrials.gov
Source updated: 2012-01-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:39 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (2)

PSA flyer

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations