Facilitating Shared Decisionmaking About Prostate Cancer Screening

April 6, 2015 updated by: US Department of Veterans Affairs
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.

Objectives:

This study evaluated two interventions designed to facilitate this process.

Methods:

1152 male veterans age 50+ with no CaP and primary care appointments at four VA medical facilities in VISN 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). Intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (T1) and one year (T2) after the target appointment. Outcomes included: a 10- item validated knowledge index; responses to questions on CaP natural history, treatment efficacy, PSA accuracy, and expert disagreement about the PSA; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and PSA testing rates.

Status:

Complete

Study Type

Interventional

Enrollment (Anticipated)

1152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System, Minneapolis, MN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Behavioral: Prostate Cancer Screening Education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Investigators

  • Principal Investigator: Melissa R. Partin, PhD, Minneapolis VA Health Care System, Minneapolis, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

December 1, 2002

Study Registration Dates

First Submitted

March 14, 2001

First Submitted That Met QC Criteria

March 15, 2001

First Posted (Estimate)

March 16, 2001

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 99-277

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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