Prostate CancerNCT00208988
A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening
A study testing Educational handout about prostate cancer screening and Simple cue for patient to talk to doctor in people with Prostate Cancer, run by Emory University at 1 site in United States.
Trial summary
Prostate cancer is the most common type of cancer among men. It is also the second leading cause of cancer-related death among men. Two screening tests are available to try to detect prostate cancer early - the digital rectal examination (DRE) and the prostate specific antigen (PSA) blood test. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Educational handout about prostate cancer screening and Simple cue for patient to talk to doctor
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Aug 2003
- 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 45 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age 45-70
Who cannot join
- Unable to communicate in English
- Too ill
- In police custody
- Visual acuity worse than 20/60
- History of prostate cancer
- Lack of cooperation
- Overt psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
About this study
Prostate cancer is the most common type of cancer among men. It is also the second leading cause of cancer-related death among men. Two screening tests are available to try to detect prostate cancer early - the digital rectal examination (DRE) and the prostate specific antigen (PSA) blood test. Unfortunately, physicians aren't sure whether or not these two screening tests help save lives, and there's a lot of controversy about how to use them. Recently, a major government committee (the U.S. Preventive Services Task Force) recommended that physicians discuss the risks and potential benefits of prostate cancer screening with their patients, and allow patients to make their own decision.
Because of the controversies, many physicians currently don't discuss prostate cancer with their patients. The problem is that it takes time and effort to have these discussions, and the information is complicated. A lot of patients have trouble understanding it, especially if they have a limited educational background or trouble reading. When patients have difficulty obtaining, understanding, and acting on basic health information, we say that they have "low health literacy." Other researchers have shown that patients with low health literacy don't know as much about cancer screening and are less likely to get screened for various cancers. They also tend to be timid about discussing things with their doctor, and often go along with what the doctor says, rather than taking an active role in the decision making.
In 2003, under IRB approval, we conducted a study with 2 goals: 1) to encourage patients to talk to their doctor about prostate cancer screening, and 2) to learn more about the impact of low health literacy on these conversations. To promote conversation, we used two handouts, given to patients in the waiting room before they saw the doctor. The first was a patient education handout about prostate cancer screening, written in very simple terms with useful illustrations. The second was a handout that simply encouraged patients to talk to their doctor about prostate cancer. Patients got one of the two handouts, or a nutritional handout that served as a control. After they saw their doctor, a research assistant briefly interviewed the patient to find out whether or not prostate cancer screening was discussed. We also measured the patients' health literacy skills, and asked a few other questions about their decision to get screened for prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Educational handout about prostate cancer screening, Simple cue for patient to talk to doctor
- Keywords
- Health literacy, Physician-Patient Relationship, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational handout about prostate cancer screeningProcedure or surgery
Simple cue for patient to talk to doctorProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Discussion of Prostate Cancer Screening
Secondary outcomes (2)
DRE
PSA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2003
- Study completionAug 2003
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 Prostate CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Investigators
- Sunil Kripalani, MD, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208988
- Sponsor's protocol ID
- 511-2005
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Publications
Kripalani S, Sharma J, Justice E, Justice J, Spiker C, Laufman LE, Price M, Weinberg AD, Jacobson TA. Low-literacy interventions to promote discussion of prostate cancer: a randomized controlled trial. Am J Prev Med. 2007 Aug;33(2):83-90. doi: 10.1016/j.amepre.2007.03.018.
PubMed 17673094
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT00208988
- Acronym / sponsor ID
- 511-2005
- Conditions
- Prostate Cancer
- Keywords
- Health literacy, Physician-Patient Relationship, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2003
- Study completion
- Aug 2003
- First posted
- 21 Sep 2005 (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.
Prostate cancer is the most common type of cancer among men. It is also the second leading cause of cancer-related death among men. Two screening tests are available to try to detect prostate cancer early - the digital rectal examination (DRE) and the prostate specific antigen (PSA) blood test. Unfortunately, physicians aren't sure whether or not these two screening tests help save lives, and there's a lot of controversy about how to use them. Recently, a major government committee (the U.S. Preventive Services Task Force) recommended that physicians discuss the risks and potential benefits of prostate cancer screening with their patients, and allow patients to make their own decision.
Because of the controversies, many physicians currently don't discuss prostate cancer with their patients. The problem is that it takes time and effort to have these discussions, and the information is complicated. A lot of patients have trouble understanding it, especially if they have a limited educational background or trouble reading. When patients have difficulty obtaining, understanding, and acting on basic health information, we say that they have "low health literacy." Other researchers have shown that patients with low health literacy don't know as much about cancer screening and are less likely to get screened for various cancers. They also tend to be timid about discussing things with their doctor, and often go along with what the doctor says, rather than taking an active role in the decision making.
In 2003, under IRB approval, we conducted a study with 2 goals: 1) to encourage patients to talk to their doctor about prostate cancer screening, and 2) to learn more about the impact of low health literacy on these conversations. To promote conversation, we used two handouts, given to patients in the waiting room before they saw the doctor. The first was a patient education handout about prostate cancer screening, written in very simple terms with useful illustrations. The second was a handout that simply encouraged patients to talk to their doctor about prostate cancer. Patients got one of the two handouts, or a nutritional handout that served as a control. After they saw their doctor, a research assistant briefly interviewed the patient to find out whether or not prostate cancer screening was discussed. We also measured the patients' health literacy skills, and asked a few other questions about their decision to get screened for prostate cancer.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male
- Age 45-70
Key exclusion criteria (7 listed)
- Unable to communicate in English
- Too ill
- In police custody
- Visual acuity worse than 20/60
- History of prostate cancer
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 |
|---|---|---|
| Educational handout about prostate cancer screening | Procedure or surgery | – |
| Simple cue for patient to talk to doctor | Procedure or surgery | – |
Primary outcome
Discussion of Prostate Cancer Screening
2 secondary outcomes
DRE
PSA
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 21 Sep 2005.
- Derived from this study: PubMed 17673094Kripalani S, Sharma J, Justice E, Justice J, Spiker C, Laufman LE, Price M, Weinberg AD, Jacobson TA. Low-literacy interventions to promote discussion of prostate cancer: a randomized controlled trial. Am J Prev Med. 2007 Aug;33(2):83-90. doi: 10.1016/j.amepre.2007.03.018.
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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.
Sunil Kripalani, MD, MSc principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational handout about prostate cancer screening and Simple cue for patient to talk to doctor in people with Prostate Cancer, run by Emory University 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 2 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 21 Sep 2005. 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?
Discussion of Prostate Cancer Screening. 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 NCT00208988, 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 21 Sep 2005.