Prostate CancerNCT01484665
Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
A study testing PROCASE Decision-Aid in people with Prostate Cancer, run by University of Minnesota at 1 site in United States.
Trial summary
Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PROCASE Decision-Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jun 2012
- 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 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males ages 50-75
- Able to read and speak English
- Provide written informed consent
Who cannot join
- Diagnosis of prostate cancer
- PSA testing within last 12 months
- Previous prostate biopsy
- Voiding problems as reason for clinic visit
- Visit scheduled same day or 'walk-In' patient
Trial locations and contacts
1 site in 1 country.
United States1 site
Broadway Family Medicine Clinic
Minneapolis, Minnesota, 55455
About this study
Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.
Read the detailed description
This pilot project will evaluate two approaches to implementing the use of a simple printed PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a significant number of African-Americans. All subjects will complete a survey assessing their knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians will also be briefly queried about their perceptions of the SDM process.
After the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of DA in the clinical setting. Another three month implementation period will follow using the same methods to assess outcomes. Finally we will conduct another round of focus groups to assess the overall impact of the interventions.
- Conditions
- Prostate Cancer
- Being tested
- PROCASE Decision-Aid
- Keywords
- PSA screening, Decision aids
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROCASE Decision-AidOther
VA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled "The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study.
| Study group | Role | What they receive |
|---|---|---|
| Participants (Males, age 50-75 yrs) | Experimental | Eligible men will be identified from the administrative database and electronic medical record at the University of Minnesota (EMR) at least 24 hours prior to the clinic visit. They will be asked to complete the PROCASE Decision-Aid. Receives: Other: PROCASE Decision-Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provider Satisfaction with Implementation of the Shared Decision Making Process
Will be determined through a combination of surveys and responses to questions derived during focus groups.
Measured: At 3-5 Months
Provider Satisfaction with Implementation of the Shared Decision Making Process
Will be determined through a combination of surveys and responses to questions derived during focus groups.
Measured: At 8-10 Months
Secondary outcomes (2)
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Will be determined through a questionnaire administered to patients.
Measured: At 8-10 Months
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Will be determined through a questionnaire administered to patients.
Measured: At 3-5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Warlick, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484665
- Sponsor's protocol ID
- 2011NTLS071
- Status last verified
- Aug 2014
- First submitted
- 29 Nov 2011
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Decision Aid on Shared Decision Making for Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT01484665
- Acronym / sponsor ID
- 2011NTLS071
- Conditions
- Prostate Cancer
- Keywords
- PSA screening, Decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Dec 2011 (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.
Decision-aids are tools to educate patients on a given topic so that they may better participate in shared-decision making in their health care. Given the complexities associated with PSA testing, many professional organizations have advocated for shared-decision making for PSA testing. However, no consensus exists as to how best educate and involve patients in the shared-decision making process. The goal of this study is to evaluate a pilot program utilizing a simple PSA screening decision-aid presented in two different fashions in a primary care clinic with a large fraction of African-American patients. The investigators will evaluate the effectiveness of this program to educate patients on the risks and benefits of prostate specific antigen (PSA) testing, on their subsequent level of comfort with their decision about whether to receive PSA testing, and on the comfort level of physicians on their patient's decisions regarding PSA testing, and importantly, how well these strategies can be implemented into the daily work-flow of a clinic. If successful, this program may serve as a model for the broader implementation of such strategies across Minnesota and the country.
Detailed description
This pilot project will evaluate two approaches to implementing the use of a simple printed PSA screening decision-aid (DA) administered in an urban primary care clinic populated with a significant number of African-Americans. All subjects will complete a survey assessing their knowledge and attitudes about PSA screening and shared decision making (SDM), and physicians will also be briefly queried about their perceptions of the SDM process.
After the first three month implementation period we will conduct focus groups with clinic staff to guide changes and refinements to the use of DA in the clinical setting. Another three month implementation period will follow using the same methods to assess outcomes. Finally we will conduct another round of focus groups to assess the overall impact of the interventions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants (Males, age 50-75 yrs) | Experimental | Other: PROCASE Decision-AidEligible men will be identified from the administrative database and electronic medical record at the University of Minnesota (EMR) at least 24 hours prior to the clinic visit. They will be asked to complete the PROCASE Decision-Aid. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males ages 50-75
- Able to read and speak English
- Provide written informed consent
Key exclusion criteria (5 listed)
- Diagnosis of prostate cancer
- PSA testing within last 12 months
- Previous prostate biopsy
- Voiding problems as reason for clinic visit
- Visit scheduled same day or 'walk-In' patient
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 |
|---|---|---|
| PROCASE Decision-AidVA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled "The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study. | Other | Participants (Males, age 50-75 yrs) |
Primary outcome
Provider Satisfaction with Implementation of the Shared Decision Making Process
Time frame: At 3-5 Months
Will be determined through a combination of surveys and responses to questions derived during focus groups.
Provider Satisfaction with Implementation of the Shared Decision Making Process
Time frame: At 8-10 Months
Will be determined through a combination of surveys and responses to questions derived during focus groups.
2 secondary outcomes
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Time frame: At 8-10 Months
Patient Satisfaction with Shared Decision Making and Reach of the Intervention
Time frame: At 3-5 Months
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 22 Aug 2014.
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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.
Christopher Warlick, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROCASE Decision-Aid in people with Prostate Cancer, run by University of Minnesota at 1 site 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 5 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 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Provider Satisfaction with Implementation of the Shared Decision Making Process (time frame: At 3-5 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2014.