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Clinical Trials/NCT02053389
NCT02053389
Completed
N/A

Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

University of Michigan1 site in 1 country564 target enrollmentNovember 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prostatic Neoplasms
Sponsor
University of Michigan
Enrollment
564
Locations
1
Primary Endpoint
Self-efficacy for discussing preferences (actual)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will:

  • increase patients' perceptions of the importance of their preferences to their decision making
  • increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists
  • increase patients' actual engagement with their physician during the clinical encounter
  • increase the concordance between patient decision making preferences and actual decision making outcomes
  • increase long term satisfaction with decision on type of treatment selected
  • increase patient satisfaction with their decision and the decision making process
  • influence patient perception of his physician (e.g., trust) and of the diagnosis visit
Registry
clinicaltrials.gov
Start Date
November 2010
End Date
February 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela Fagerlin

Associate Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 years and older
  • Scheduled for a prostate biopsy to test for prostate cancer
  • Ability to read and answer survey questions in English

Exclusion Criteria

  • Previous diagnosis of prostate cancer

Outcomes

Primary Outcomes

Self-efficacy for discussing preferences (actual)

Time Frame: Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline)

14 item survey instrument

Self-efficacy for discussing preferences (intention)

Time Frame: Time 2 (post-intervention, an average of 3 days after Time 1 baseline)

14 item survey instrument

Secondary Outcomes

  • Treatment preference(Time 2 (post-intervention, an average of 3 days after Time 1 baseline))
  • Preference for shared decision making(Time 4 (6 months post diagnosis))
  • Decisional regret(Time 4 (6 months post diagnosis))
  • Prostate cancer related knowledge(Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline))
  • Prostate cancer related anxiety(Time 4 (6 months post diagnosis))
  • Treatment decision(Time 4 (6 months post diagnosis))

Study Sites (1)

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