Clinical trial NCT00454766: Evaluating Materials to Educate Patients About Cervical Dysplasia
Official title: Evaluating Materials to Educate Patients About Cervical Dysplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Education
Cervical Dysplasia
Keywords: Patient Education
Cervical Dysplasia
Questionnaire
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-04-02
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women, over 18 years of age, with an abnormal Papanicolaou (Pap) smear are referred for a colposcopy and biopsy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy.
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Karen Basen-Engquist, PhD
role: PRINCIPAL_INVESTIGATOR
References: