Evaluating Materials to Educate Patients About Cervical Dysplasia

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00454766

Collaborator

(none)

Enrollment

Location

216

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Education Cervical Dysplasia	Behavioral: Questionnaire

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Evaluating Materials to Educate Patients About Cervical Dysplasia

Actual Study Start Date :

Feb 1, 2007

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Questionnaire Questionnaire Regarding Tailored Educational Materials	Behavioral: Questionnaire Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level. Other Names: Survey

Arm

Intervention/Treatment

Questionnaire

Questionnaire Regarding Tailored Educational Materials

Behavioral: Questionnaire

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

Other Names:

Survey

Outcome Measures

Primary Outcome Measures

To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy. [2 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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