NCT00454766

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2007

Completed
16.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

17 years

First QC Date

March 29, 2007

Last Update Submit

December 29, 2020

Conditions

EducationCervical Dysplasia

Keywords

Patient EducationCervical DysplasiaQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • To study the importance of tailoring patient education materials to colposcopy patients' level of health literacy.

    2 Years

Study Arms (1)

Questionnaire

Questionnaire Regarding Tailored Educational Materials

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Survey of two educational brochures with approximately the same information, but which vary in their health literacy (readability) level.

Also known as: Survey
Questionnaire

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Over 18 years old;
  • Follow up colposcopy clinic patients who completed a colposcopy and treatment (if indicated) at an earlier date;
  • Able to communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Karen Karen Basen-Engquist, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2007

First Posted

April 2, 2007

Study Start

February 1, 2007

Primary Completion

February 1, 2024

Study Completion

February 1, 2025

Last Updated

December 30, 2020

Record last verified: 2020-12

Locations

US(1)