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Sponsors and Collaborators: |
University of North Carolina RTI International |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00630188 |
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.
Condition | Intervention |
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Prostatic Neoplasms |
Other: You Decide Other: Reducing Your Risks in the Crash |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial |
Enrollment: | 128 |
Study Start Date: | March 2005 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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 |
2: Active Comparator
Highway Safety video
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Other: Reducing Your Risks in the Crash
Publicly available video on highway safety and reducing individual risks in a crash
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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.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
University of North Carolina at Chapel Hill General Medicine Clinic | |
Chapel Hill, North Carolina, United States, 27599 | |
Chapel Hill North General Internal Medicine Practice | |
Chapel Hill, North Carolina, United States, 27516 | |
Triad Internal Medicine | |
Greensboro, North Carolina, United States, 27405 | |
Moses Cone Internal Medicine Practice | |
Greensboro, North Carolina, United States, 27401 |
Principal Investigator: | Russ Harris, MD, MPH | The University of North Carolina, Chapel Hill |
Principal Investigator: | Lauren McCormack, PhD, MSPH | RTI International |
Principal Investigator: | David Driscoll, PhD, MSPH | RTI International |
Responsible Party: | University of North Carolina at Chapel Hill ( Russell P Harris ) |
Study ID Numbers: | TS-0845 |
Study First Received: | February 28, 2008 |
Last Updated: | March 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00630188 |
Health Authority: | United States: Institutional Review Board |
prostate cancer screening shared decision making prostate-specific antigen decision making physician-patient relations |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |