Prostatic NeoplasmsNCT00630188
Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
A study testing You Decide and Reducing Your Risks in the Crash in people with Prostatic Neoplasms, run by University of North Carolina at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- You Decide and Reducing Your Risks in the Crash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 40-80 years
- Their physician agreed to participate in the study
- Seen in practice for at least one year
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Chapel Hill North General Internal Medicine Practice
Chapel Hill, North Carolina, 27516
University of North Carolina at Chapel Hill General Medicine Clinic
Chapel Hill, North Carolina, 27599
Moses Cone Internal Medicine Practice
Greensboro, North Carolina, 27401
Triad Internal Medicine
Greensboro, North Carolina, 27405
About this study
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.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- You Decide, Reducing Your Risks in the Crash
- Keywords
- prostate cancer screening, shared decision making, prostate-specific antigen, decision making, physician-patient relations
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
You DecideOther
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 CrashOther
Publicly available video on highway safety and reducing individual risks in a crash
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Other: You Decide |
| 2 | Active comparator | Highway Safety video Receives: Other: Reducing Your Risks in the Crash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Men's understanding that prostate cancer screening requires a decision
Measured: baseline, post intervention, post clinical visit
Men's knowledge about prostate cancer and prostate cancer screening
Measured: baseline, post intervention, post clinical visit
Men's participation in the decision about prostate cancer screening with their clinician at their preferred level
Measured: baseline, post intervention, post clinical visit
Secondary outcomes (4)
The presence of a shared decision
Measured: post clinical visit
men's intent to be screened for prostate cancer
Measured: post clinical visit
Self reported screening
Measured: post visit
Actual screening by chart review
Measured: 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startMar 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- RTI International
- Investigators
- Russ Harris, MD, MPH, Principal investigator, University of North Carolina, Chapel HillLauren McCormack, PhD, MSPH, Principal investigator, RTI InternationalDavid Driscoll, PhD, MSPH, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630188
- Sponsor's protocol ID
- TS-0845
- Status last verified
- Feb 2008
- First submitted
- 28 Feb 2008
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Sheridan SL, Golin C, Bunton A, Lykes JB, Schwartz B, McCormack L, Driscoll D, Bangdiwala SI, Harris RP. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials. BMC Med Inform Decis Mak. 2012 Nov 13;12:130. doi: 10.1186/1472-6947-12-130.
PubMed 23148458
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making for Prostate Cancer Screening: a Practice-Based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00630188
- Acronym / sponsor ID
- TS-0845
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate cancer screening, shared decision making, prostate-specific antigen, decision making, physician-patient relations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of North CarolinaUniversity, hospital or other
- Collaborators
- RTI International
- Study start
- Mar 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: You DecideFor 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 |
| 2 | Active comparator | Other: Reducing Your Risks in the CrashHighway Safety video |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 40-80 years
- Their physician agreed to participate in the study
- Seen in practice for at least one year
Key exclusion criteria (7 listed)
- Prior history of prostate cancer
- Presenting for acute medical visit
- Non-skin cancer
- Lung disease requiring oxygen
- Renal failure requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| You DecideFor 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 | Other | 1 |
| Reducing Your Risks in the CrashPublicly available video on highway safety and reducing individual risks in a crash | Other | 2 |
Primary outcome
Men's understanding that prostate cancer screening requires a decision
Time frame: baseline, post intervention, post clinical visit
Men's knowledge about prostate cancer and prostate cancer screening
Time frame: baseline, post intervention, post clinical visit
Men's participation in the decision about prostate cancer screening with their clinician at their preferred level
Time frame: baseline, post intervention, post clinical visit
4 secondary outcomes
The presence of a shared decision
Time frame: post clinical visit
men's intent to be screened for prostate cancer
Time frame: post clinical visit
Self reported screening
Time frame: post visit
Actual screening by chart review
Time frame: 9 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2008.
- Derived from this study: PubMed 23148458Sheridan SL, Golin C, Bunton A, Lykes JB, Schwartz B, McCormack L, Driscoll D, Bangdiwala SI, Harris RP. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials. BMC Med Inform Decis Mak. 2012 Nov 13;12:130. doi: 10.1186/1472-6947-12-130.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russ Harris, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Lauren McCormack, PhD, MSPH principal investigator
RTI International
David Driscoll, PhD, MSPH principal investigator
RTI International
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing You Decide and Reducing Your Risks in the Crash in people with Prostatic Neoplasms, run by University of North Carolina at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Men's understanding that prostate cancer screening requires a decision (time frame: baseline, post intervention, post clinical visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00630188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2008.