Patient-centered Educational Material to Improve Colposcopy Adherence

Not Applicable

Recruiting

• Conditions: Cervical Cancer Screening

• Registration Number: NCT05762757
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The long-term goal is to develop, test, and disseminate a social needs navigator intervention that improves colposcopy adherence. Based on stakeholder feedback, this study addresses the need to include patient-centered educational material to the navigator program in order to improve patients' health literacy regarding cervical cancer prevention.

Detailed Description

The investigators will evaluate the effectiveness of the colposcopy educational material. The investigators aim to recruit 25 newly referred colposcopy patients before their appointment, ask them to take a 5-minute test about their knowledge of colposcopy, have them view an online demo of the educational resources, and then retake the test.

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-10
• Study Start: 2024-01-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• Age 21 years or older
• Abnormal cervical screen confirmed by cytology or pathology
• Referred to Washington University School of Medicine (WUSM) colposcopy clinic

Exclusion Criteria

• History of cervical cancer
• Unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in participant knowledge of colposcopy	Prior to viewing educational material and after viewing educational material (Day 1)	-9 question questionnaire that will assess patient knowledge of colposcopy

Secondary Outcome Measures

Name	Time	Method
Feasibility of educational material as measured by the Feasibility of Intervention Measure	Day 1
Number of participants who stated that the educational material will influence their intention to adhere to colposcopy	Day 1	This is a 4-item measure of perceived intervention feasibility. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.
Acceptability of educational material as measured by the Acceptability of Intervention Measure	Day 1	This is a 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.
Appropriateness of educational material as measured by the Intervention Appropriateness Measure	Day 1	This is a 4-item measure of perceived intervention appropriateness. Items are measured on a 5-point Likert scale (Completely disagree-completely agree). Mean score is calculated.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States