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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
You Decide
Reducing Your Risks in the Crash
Sponsored by
University of North Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostatic Neoplasms focused on measuring prostate cancer screening, shared decision making, prostate-specific antigen, decision making, physician-patient relations

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chapel Hill North General Internal Medicine Practice
  • University of North Carolina at Chapel Hill General Medicine Clinic
  • Moses Cone Internal Medicine Practice
  • Triad Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

Highway Safety video

Outcomes

Primary Outcome Measures

Men's understanding that prostate cancer screening requires a decision
Men's knowledge about prostate cancer and prostate cancer screening
Men's participation in the decision about prostate cancer screening with their clinician at their preferred level

Secondary Outcome Measures

The presence of a shared decision
men's intent to be screened for prostate cancer
Self reported screening
Actual screening by chart review

Full Information

First Posted
February 28, 2008
Last Updated
March 5, 2008
Sponsor
University of North Carolina
Collaborators
RTI International
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1. Study Identification

Unique Protocol Identification Number
NCT00630188
Brief Title
Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Official Title
Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of North Carolina
Collaborators
RTI International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
prostate cancer screening, shared decision making, prostate-specific antigen, decision making, physician-patient relations

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
Highway Safety video
Intervention Type
Other
Intervention Name(s)
You Decide
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Reducing Your Risks in the Crash
Intervention Description
Publicly available video on highway safety and reducing individual risks in a crash
Primary Outcome Measure Information:
Title
Men's understanding that prostate cancer screening requires a decision
Time Frame
baseline, post intervention, post clinical visit
Title
Men's knowledge about prostate cancer and prostate cancer screening
Time Frame
baseline, post intervention, post clinical visit
Title
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
Secondary Outcome Measure Information:
Title
The presence of a shared decision
Time Frame
post clinical visit
Title
men's intent to be screened for prostate cancer
Time Frame
post clinical visit
Title
Self reported screening
Time Frame
post visit
Title
Actual screening by chart review
Time Frame
9 month follow-up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russ Harris, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren McCormack, PhD, MSPH
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Driscoll, PhD, MSPH
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chapel Hill North General Internal Medicine Practice
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States
Facility Name
University of North Carolina at Chapel Hill General Medicine Clinic
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Moses Cone Internal Medicine Practice
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Triad Internal Medicine
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23148458
Citation
Sheridan SL, Golin C, Bunton A, Lykes JB, Schwartz B, McCormack L, Driscoll D, Bangdiwala SI, Harris RP. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials. BMC Med Inform Decis Mak. 2012 Nov 13;12:130. doi: 10.1186/1472-6947-12-130.
Results Reference
derived

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

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