Patient-centered Educational Material to Improve Colposcopy Adherence

NCT05762757 | Completed

• 1 other identifier: 202208064
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer Screening

Keywords

cervical cancer screening; colposcopy; patient education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acceptability of educational material as measured by the Acceptability of Intervention Measure

  Day 1

• Appropriateness of educational material as measured by the Intervention Appropriateness Measure

  Day 1

• 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

Study Arms (1)

Colposcopy educational material

EXPERIMENTAL

Participants will complete a 9-question quiz that will assess knowledge of colposcopy. They will then view the colposcopy educational material and answer the same 9-question quiz to assess their knowledge of colposcopy. Participants will complete the Acceptability Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Participants will also be asked whether the educational material influences their intention to adhere to colposcopy.

Other: Colposcopy educational material

Interventions

Colposcopy educational material OTHER

-Will consist of a handout featuring education and information regarding colposcopies.

Colposcopy educational material

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of cervical cancer
• Unable to consent

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American Association of Obstetricians and Gynecologists: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Lindsay M Kuroki, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 10, 2023
• Study Start: January 30, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)