Patient-centered Educational Material to Improve Colposcopy Adherence

Cervical Cancer Screening Clinical Trial

Official title:

Patient-centered Educational Material to Improve Colposcopy Adherence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762757
• Other study ID #: 202208064
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: Washington University School of Medicine
• Contact: Lindsay M Kuroki, M.D.
• Phone: 314-362-2368
• Email: kurokil[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer Screening
• Uterine Cervical Neoplasms

Intervention

Other:
• Colposcopy educational material
-Will consist of a handout featuring education and information regarding colposcopies.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Association of Obstetricians and Gynecologists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in participant knowledge of colposcopy	-9 question questionnaire that will assess patient knowledge of colposcopy	Prior to viewing educational material and after viewing educational material (Day 1)
Secondary	Acceptability of educational material as measured by the Acceptability of Intervention Measure	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.	Day 1
Secondary	Appropriateness of educational material as measured by the Intervention Appropriateness Measure	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.	Day 1
Secondary	Feasibility of educational material as measured by the Feasibility of Intervention Measure		Day 1
Secondary	Number of participants who stated that the educational material will influence their intention to adhere to colposcopy	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.	Day 1

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine