Prostatic Neoplasms
Conditions
Keywords
prostate cancer screening, shared decision making, prostate-specific antigen, decision making, physician-patient relations
Brief 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.
Detailed 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.
Interventions
OTHERYou 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
OTHERReducing Your Risks in the Crash
Publicly available video on highway safety and reducing individual risks in a crash
Sponsors
RTI International
University of North Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Men's understanding that prostate cancer screening requires a decision | baseline, post intervention, post clinical visit |
| Men's knowledge about prostate cancer and prostate cancer screening | baseline, post intervention, post clinical visit |
| Men's participation in the decision about prostate cancer screening with their clinician at their preferred level | baseline, post intervention, post clinical visit |
Secondary
| Measure | Time frame |
|---|---|
| The presence of a shared decision | post clinical visit |
| Actual screening by chart review | 9 month follow-up |
| men's intent to be screened for prostate cancer | post clinical visit |
| Self reported screening | post visit |
Countries
United States
Outcome results
None listed