Evaluating Materials to Educate Patients About Cervical Dysplasia
| Tracking Information | |||||
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| First Received Date ICMJE | March 29, 2007 | ||||
| Last Updated Date | September 10, 2012 | ||||
| Start Date ICMJE | February 2007 | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00454766 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating Materials to Educate Patients About Cervical Dysplasia | ||||
| Official Title ICMJE | Evaluating Materials to Educate Patients About Cervical Dysplasia | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Questionnaire
Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.
Other Name: Survey |
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| Study Group/Cohort (s) | Questionnaire
Questionnaire Regarding Tailored Educational Materials
Intervention: Behavioral: Questionnaire |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None |
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00454766 | ||||
| Other Study ID Numbers ICMJE | 2006-1014 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | September 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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