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

40 Years
80 Years
Not Enrolling
Prostatic Neoplasms

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Men's understanding that prostate cancer screening requires a decision

Outcome Time Frame:

baseline, post intervention, post clinical visit

Safety Issue:


Principal Investigator

Russ Harris, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina, Chapel Hill


United States: Institutional Review Board

Study ID:




Start Date:

March 2005

Completion Date:

April 2006

Related Keywords:

  • Prostatic Neoplasms
  • prostate cancer screening
  • shared decision making
  • prostate-specific antigen
  • decision making
  • physician-patient relations
  • Neoplasms
  • Prostatic Neoplasms



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