Evaluating Materials to Educate Patients About Cervical Dysplasia

Education Clinical Trial

Official title:

Evaluating Materials to Educate Patients About Cervical Dysplasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00454766
• Other study ID #: 2006-1014
• Status: Active, not recruiting
• Start date: February 2007
• Est. completion date: February 2025

Study information

• Verified date: December 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Cervical Intraepithelial Neoplasia
• Education
• Hyperplasia
• Uterine Cervical Dysplasia

Intervention

Behavioral:
• Questionnaire
Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy.		2 Years

External Links

•   University of Texas MD Anderson Cancer Center Website