Evaluating Materials to Educate Patients About Cervical Dysplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00454766
First received: March 29, 2007
Last updated: September 11, 2014
Last verified: September 2014

March 29, 2007
September 11, 2014
February 2007
December 2015   (final data collection date for primary outcome measure)
To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00454766 on ClinicalTrials.gov Archive Site
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Evaluating Materials to Educate Patients About Cervical Dysplasia
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Women, over 18 years of age, with an abnormal Papanicolaou (Pap) smear are referred for a colposcopy and biopsy.

  • Education
  • Cervical Dysplasia
Behavioral: Questionnaire
Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.
Other Name: Survey
Questionnaire
Questionnaire Regarding Tailored Educational Materials
Intervention: Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
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December 2015   (final data collection date for primary outcome measure)

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

Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00454766
2006-1014
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Karen Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP