Prostate Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

128

Study ID:

NCT00630188

Recruitment Status:

Completed

Sponsor:

University of North Carolina

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There are 4 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

128

Study ID:

NCT00630188

Recruitment Status:

Completed

Sponsor:


University of North Carolina

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