A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening
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|ClinicalTrials.gov Identifier: NCT00208988|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Procedure: Educational handout about prostate cancer screening Procedure: Simple cue for patient to talk to doctor|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening|
|Study Start Date :||May 2003|
|Estimated Study Completion Date :||August 2003|
- Discussion of Prostate Cancer Screening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208988
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Sunil Kripalani, MD, MSc||Emory University|