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Clinical Trials/NCT00630188
NCT00630188
Completed
N/A

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

University of North Carolina4 sites in 1 country128 target enrollmentMarch 2005

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
University of North Carolina
Enrollment
128
Locations
4
Primary Endpoint
Men's understanding that prostate cancer screening requires a decision
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
April 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

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

Outcomes

Primary Outcomes

Men's understanding that prostate cancer screening requires a decision

Time Frame: baseline, post intervention, post clinical visit

Men's knowledge about prostate cancer and prostate cancer screening

Time Frame: 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

Secondary Outcomes

  • The presence of a shared decision(post clinical visit)
  • men's intent to be screened for prostate cancer(post clinical visit)
  • Self reported screening(post visit)
  • Actual screening by chart review(9 month follow-up)

Study Sites (4)

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