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
  Purpose

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
Education
Cervical Dysplasia
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating Materials to Educate Patients About Cervical Dysplasia

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: February 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Survey

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454766

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00454766     History of Changes
Other Study ID Numbers: 2006-1014
Study First Received: March 29, 2007
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Patient Education
Cervical Dysplasia
Questionnaire

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Carcinoma
Carcinoma in Situ
Genital Diseases, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Uterine Cervical Diseases
Uterine Diseases

ClinicalTrials.gov processed this record on October 21, 2014