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A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00208988
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Information provided by:

September 13, 2005
September 21, 2005
September 21, 2005
May 2003
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Discussion of Prostate Cancer Screening
Same as current
No Changes Posted
  • DRE
  • PSA
Same as current
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A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening
A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening

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.

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Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Prostate Cancer
  • Procedure: Educational handout about prostate cancer screening
  • Procedure: Simple cue for patient to talk to doctor
Not Provided
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. Erratum in: Am J Prev Med. 2008 Mar;34(3):270. Jacobson, Terry A [added].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2003
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Inclusion Criteria:

  • Male
  • Age 45-70

Exclusion Criteria:

  • 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
Sexes Eligible for Study: Male
45 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Emory University
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Principal Investigator: Sunil Kripalani, MD, MSc Emory University
Emory University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP