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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630188
• Other study ID #: TS-0845
• Status: Completed
• Phase: N/A
• First received: February 28, 2008
• Last updated: March 5, 2008
• Start date: March 2005
• Est. completion date: April 2006

Study information

• Verified date: February 2008
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

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
• Reducing Your Risks in the Crash
Publicly available video on highway safety and reducing individual risks in a crash

Locations

Country	Name	City	State
United States	Chapel Hill North General Internal Medicine Practice	Chapel Hill	North Carolina
United States	University of North Carolina at Chapel Hill General Medicine Clinic	Chapel Hill	North Carolina
United States	Moses Cone Internal Medicine Practice	Greensboro	North Carolina
United States	Triad Internal Medicine	Greensboro	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina	RTI International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Men's understanding that prostate cancer screening requires a decision		baseline, post intervention, post clinical visit	No
Primary	Men's knowledge about prostate cancer and prostate cancer screening		baseline, post intervention, post clinical visit	No
Primary	Men's participation in the decision about prostate cancer screening with their clinician at their preferred level		baseline, post intervention, post clinical visit	No
Secondary	The presence of a shared decision		post clinical visit	No
Secondary	men's intent to be screened for prostate cancer		post clinical visit	No
Secondary	Self reported screening		post visit	No
Secondary	Actual screening by chart review		9 month follow-up	No