- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00454766
Evaluating Materials to Educate Patients About Cervical Dysplasia
Primary Objective:
To pilot test high and low literacy patient education materials for colposcopy clinic patients, assessing impact on patient knowledge and patient feedback about the materials.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Women with an abnormal Papanicolaou (Pap) smear are typically referred for a colposcopy and biopsy. However, data collected by research groups and others shows that women with abnormal Pap smear results have limited understanding of the meaning of the results, the causes of cervical dysplasia, and the procedures used to evaluate and treat it. This situation is further complicated by the fact that many patients, particularly those with less education, have low health literacy in general. This means that much of the existing patient education materials will likely be inappropriate or ineffective for this group. One approach is to develop materials at low literacy levels; however, it is not known whether such materials will be provide sufficient information and be effective for patients with high health literacy.
The long term goal is to study the importance of tailoring patient education materials to colposcopy patients' level of health literacy. To this end, researchers have developed two educational brochures with approximately the same information, but which vary in their health literacy (readability) level. As a first step in this research, researchers propose to present these materials to colposcopy patients returning for colposcopy visits to assess changes in knowledge and obtain patient feedback on the brochures.
The proposed pilot study represents the first step at evaluating the patient education materials and determining the patient's level of understanding of what they receive.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years old;
- Follow up colposcopy clinic patients who completed a colposcopy and treatment (if indicated) at an earlier date;
- Able to communicate in English
Exclusion Criteria: None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Questionnaire
Questionnaire Regarding Tailored Educational Materials
|
Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy.
Time Frame: 2 Years
|
2 Years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karen Karen Basen-Engquist, PhD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-1014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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