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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

Other trials in United States

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.

  1. Discussion of Prostate Cancer Screening

Secondary outcomes (2)
  1. DRE

  2. PSA

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2005 (estimated)
  2. Study startMay 2003
  3. Study completionAug 2003

Resources

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
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

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.

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