Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial

March 5, 2008 updated by: University of North Carolina
The purpose of this study is to determine whether an intervention designed to help men share decisions about prostate cancer screening with their physician results in better decision making, more shared decisions, and changes in intended and actual screening rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Professional societies recommend shared decision making for prostate cancer screening, however, most effort has been directed at informed rather than shared decision making. In this study, we plan to test the effects of a shared decision making intervention on key components of shared decision making. We secondarily plan to test its effects on the presence of a shared decision, men's intention to be screened, and actual screening rates.

Methods: We plan to conduct two separate randomized controlled trials of shared decision making interventions, one in which the intervention focuses on prostate cancer screening only and one in which the intervention focuses on prostate cancer screening in the context of other men's health issues. Each trial will use the same attention control and identical implementation and measurement strategies to allow combination of data if no differences exist in the effect of the interventions. Trials will include a convenience sample of men with no prior history of prostate cancer who present to their primary care physician for routine care. Men will be randomly assigned to a shared decision making intervention (including a video and coaching session for patients and an education session for providers) or a control group, in which men will receive a video on highway safety. Data on key components of shared decision making and intent for screening will be measured at baseline, after the intervention, and after men's visit with their provider. Additionally, medical charts will be reviewed 9 months later to assess for actual screening.

Study Type

Interventional

Enrollment (Actual)

128

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
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27516
        • Chapel Hill North General Internal Medicine Practice
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill General Medicine Clinic
      • Greensboro, North Carolina, United States, 27401
        • Moses Cone Internal Medicine Practice
      • Greensboro, North Carolina, United States, 27405
        • Triad Internal Medicine

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Ages 40-80 years
  • Their physician agreed to participate in the study
  • Seen in practice for at least one year

Exclusion Criteria:

  • Prior history of prostate cancer
  • Presenting for acute medical visit
  • Non-skin cancer
  • Lung disease requiring oxygen
  • Renal failure requiring dialysis
  • Intensive care visit in last 6 months
  • Need assistance with activities of daily living

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with physician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making
Other: You Decide

For Patients: Video-based decision aid on prostate cancer screening, One-on-One values clarification session with research assistant, One-on-One coaching session with research assistant to encourage good interaction with clinician

For Physicians: a one-time educational session on prostate cancer and the value of shared decision making
Active Comparator: 2
Highway Safety video
Other: Reducing Your Risks in the Crash
Publicly available video on highway safety and reducing individual risks in a crash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Men's understanding that prostate cancer screening requires a decision
Time Frame: baseline, post intervention, post clinical visit
baseline, post intervention, post clinical visit
Men's knowledge about prostate cancer and prostate cancer screening
Time Frame: baseline, post intervention, post clinical visit
baseline, post intervention, post clinical visit
Men's participation in the decision about prostate cancer screening with their clinician at their preferred level
Time Frame: baseline, post intervention, post clinical visit
baseline, post intervention, post clinical visit

Secondary Outcome Measures

Outcome Measure
Time Frame
The presence of a shared decision
Time Frame: post clinical visit
post clinical visit
men's intent to be screened for prostate cancer
Time Frame: post clinical visit
post clinical visit
Self reported screening
Time Frame: post visit
post visit
Actual screening by chart review
Time Frame: 9 month follow-up
9 month follow-up

Collaborators and Investigators

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

Sponsor

University of North Carolina

Collaborators

RTI International

Investigators

  • Principal Investigator: Russ Harris, MD, MPH, University of North Carolina, Chapel Hill
  • Principal Investigator: Lauren McCormack, PhD, MSPH, RTI International
  • Principal Investigator: David Driscoll, PhD, MSPH, RTI International

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 Start

March 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2008

Last Update Submitted That Met QC Criteria

March 5, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS-0845

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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