Overview

This trial is active, not recruiting.

Conditions education, cervical dysplasia
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Start date February 2007
End date December 2017
Trial size 80 participants
Trial identifier NCT00454766, 2006-1014

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Questionnaire Regarding Tailored Educational Materials
questionnaire Survey
Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.

Primary Outcomes

Measure
To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy.
time frame: 2 Years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: 1. Over 18 years old; 2. Follow up colposcopy clinic patients who completed a colposcopy and treatment (if indicated) at an earlier date; 3. Able to communicate in English Exclusion Criteria: None

Additional Information

Official title Evaluating Materials to Educate Patients About Cervical Dysplasia
Principal investigator Karen Karen Basen-Engquist, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.