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

University of North Carolina (UNC)

Status: Completed

Conditions: Prostatic Neoplasms

Treatments: Other: Reducing Your Risks in the Crash; Other: You Decide

Study type: Interventional

Funder types: Other

Identifiers

NCT00630188

TS-0845

Details and patient eligibility

About

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.

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.

Enrollment: 128 patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Other: You Decide

2

Active Comparator group

Description:

Highway Safety video

Treatment:

Other: Reducing Your Risks in the Crash