Prostate Cancer ScreeningNCT01516801
A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
A study testing PSA flyer in people with Prostate Cancer Screening, run by University of Colorado, Denver at 1 site in United States.
Trial summary
1. Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the… Read more about this study
- Who is it for?
- Ages 50 to 74 years, men only
- Conditions the study is for
- Prostate Cancer Screening
- What is being tested?
- PSA flyer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 2010
- 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 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 50-74 who were cared for in a general internal medicine clinic
- had scheduled an annual health exam
- had not had a PSA test within the previous year
Who cannot join
- active cancer diagnosis
- history of prostate cancer
- need for PSA surveillance
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
- Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?
- Do patients find the flyer useful and understandable?
Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.
- Conditions
- Prostate Cancer Screening
- Being tested
- PSA flyer
- Keywords
- Prostate Cancer Screening, Pragmatic Trial, Health Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA flyerOther
A mailed low-literacy informational patient flyer about the PSA test
| Study group | Role | What they receive |
|---|---|---|
| PSA flyer | Experimental | Not described Receives: Other: PSA flyer |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PSA testing
Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical
Measured: At the time of the annual exam (within two weeks of their annual physical)
Rate of documented PSA discussions
Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.
Measured: At the time of the annual exam (within two weeks of their annual physical)
Secondary outcomes (3)
Flyer acceptability
The acceptability of the flyer will be assessed through a follow-up phone interview of patients who had received the flyer.
Measured: Within two weeks of the annual exam
Perceived participation
Perceived participation will be assessed in a follow-up phone interview within two weeks of the annual physical using validated measures of particiption in decision making.
Measured: Within two weeks
Prostate Cancer Screening knowledge
Prostate cancer screening knowledge will be assessed using 5 knowledge questions surrounding PSA testing during a follow-up interview 2 weeks after the annual physical
Measured: Within two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516801
- Sponsor's protocol ID
- 10-0603
- Status last verified
- Jan 2012
- First submitted
- 10 Jan 2012
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
- ClinicalTrials.gov ID
- NCT01516801
- Acronym / sponsor ID
- 10-0603
- Conditions
- Prostate Cancer Screening
- Keywords
- Prostate Cancer Screening, Pragmatic Trial, Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Jan 2012 (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.
- Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?
- Do patients find the flyer useful and understandable?
Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSA flyer | Experimental | Other: PSA flyer |
| Control | No intervention | – |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men age 50-74 who were cared for in a general internal medicine clinic
- had scheduled an annual health exam
- had not had a PSA test within the previous year
Key exclusion criteria (3 listed)
- active cancer diagnosis
- history of prostate cancer
- need for PSA surveillance
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 |
|---|---|---|
| PSA flyerA mailed low-literacy informational patient flyer about the PSA test | Other | PSA flyer |
Primary outcome
Rate of PSA testing
Time frame: At the time of the annual exam (within two weeks of their annual physical)
Rate of PSA testing will be determined by reviewing the chart of enrolled patients within two weeks of their annual physical
Rate of documented PSA discussions
Time frame: At the time of the annual exam (within two weeks of their annual physical)
Rate of documented PSA discussions will be determined through chart review within two weeks of the annual physical.
3 secondary outcomes
Flyer acceptability
Time frame: Within two weeks of the annual exam
Perceived participation
Time frame: Within two weeks
Prostate Cancer Screening knowledge
Time frame: Within two weeks
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 25 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA flyer in people with Prostate Cancer Screening, run by University of Colorado, Denver 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 3 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 25 Jan 2012. 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?
Rate of PSA testing (time frame: At the time of the annual exam (within two weeks of their annual physical)). 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 25 Jan 2012.