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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational handout about prostate cancer screening
Simple cue for patient to talk to doctor
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Prostate Cancer focused on measuring Health literacy, Physician-Patient Relationship, Prostate Cancer

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Grady Memorial Hospital

Outcomes

Primary Outcome Measures

Discussion of Prostate Cancer Screening

Secondary Outcome Measures

DRE
PSA

Full Information

First Posted
September 13, 2005
Last Updated
September 13, 2005
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00208988
Brief Title
A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening
Official Title
A Randomized Controlled Trial to Promote Physician-Patient Discussion of Prostate Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Emory University

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Health literacy, Physician-Patient Relationship, Prostate Cancer

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
250 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Educational handout about prostate cancer screening
Intervention Type
Procedure
Intervention Name(s)
Simple cue for patient to talk to doctor
Primary Outcome Measure Information:
Title
Discussion of Prostate Cancer Screening
Secondary Outcome Measure Information:
Title
DRE
Title
PSA

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Kripalani, MD, MSc
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17673094
Citation
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. Erratum In: Am J Prev Med. 2008 Mar;34(3):270. Jacobson, Terry A [added].
Results Reference
derived

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

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