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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00454766 |
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 | Intervention |
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Education Cervical Dysplasia |
Behavioral: Questionnaire |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Evaluating Materials to Educate Patients About Cervical Dysplasia |
Estimated Enrollment: | 80 |
Study Start Date: | February 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Questionnaire Regarding Tailored Educational Materials
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Behavioral: Questionnaire
Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Women, over 18 years of age, with an abnormal Papanicolaou (Pap) smear are referred for a colposcopy and biopsy.
Inclusion Criteria:
Exclusion Criteria: None
United States, Texas | |
U.T. M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Karen Karen Basen-Engquist, PhD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | UT MD Anderson Cancer Center ( Karen Basen-Engquist, PhD, BA, MPH/Professor ) |
Study ID Numbers: | 2006-1014 |
Study First Received: | March 29, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00454766 History of Changes |
Health Authority: | United States: Institutional Review Board |
Patient Education Cervical Dysplasia Questionnaire |
Genital Diseases, Female Uterine Cervical Diseases Precancerous Conditions Carcinoma in Situ Uterine Diseases |
Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Genital Diseases, Female Uterine Cervical Diseases Neoplasms Neoplasms by Histologic Type Precancerous Conditions Carcinoma in Situ |
Uterine Diseases Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |