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Patient-centered Educational Material to Improve Colposcopy Adherence

Primary Purpose

Cervical Cancer Screening

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Colposcopy educational material

About this trial

This is an interventional prevention trial for Cervical Cancer Screening focused on measuring cervical cancer screening, colposcopy, patient education

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colposcopy educational material

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in participant knowledge of colposcopy

-9 question questionnaire that will assess patient knowledge of colposcopy

Secondary Outcome Measures

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.

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.

Feasibility of educational material as measured by the Feasibility of Intervention Measure

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.

Full Information

NCT ID

NCT05762757

First Posted

February 20, 2023

Last Updated

October 2, 2023

Sponsor

Washington University School of Medicine

Collaborators

American Association of Obstetricians and Gynecologists

1. Study Identification

Unique Protocol Identification Number

NCT05762757

Brief Title

Patient-centered Educational Material to Improve Colposcopy Adherence

Official Title

Patient-centered Educational Material to Improve Colposcopy Adherence

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 30, 2023 (Anticipated)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Washington University School of Medicine

Collaborators

American Association of Obstetricians and Gynecologists

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer Screening

Keywords

cervical cancer screening, colposcopy, patient education

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colposcopy educational material

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Colposcopy educational material

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in participant knowledge of colposcopy

Description

-9 question questionnaire that will assess patient knowledge of colposcopy

Time Frame

Prior to viewing educational material and after viewing educational material (Day 1)

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Day 1

Title

Appropriateness of educational material as measured by the Intervention Appropriateness Measure

Description

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.

Time Frame

Day 1

Title

Feasibility of educational material as measured by the Feasibility of Intervention Measure

Time Frame

Day 1

Title

Number of participants who stated that the educational material will influence their intention to adhere to colposcopy

Description

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.

Time Frame

Day 1

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lindsay M Kuroki, M.D.

Phone

314-362-2368

kurokil@wustl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lindsay M Kuroki, M.D.

Organizational Affiliation

Washington University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lindsay M Kuroki, M.D.

Phone

314-362-2368

kurokil@wustl.edu

First Name & Middle Initial & Last Name & Degree

Lindsay M Kuroki, M.D.

First Name & Middle Initial & Last Name & Degree

L. Stewart Massad, M.D.

First Name & Middle Initial & Last Name & Degree

Mary Mullen, M.D.

First Name & Middle Initial & Last Name & Degree

Andrea Hagemann, M.D.

First Name & Middle Initial & Last Name & Degree

David G Mutch, M.D.

First Name & Middle Initial & Last Name & Degree

Matthew A Powell, M.D.

First Name & Middle Initial & Last Name & Degree

Premal H Thaker, M.D., M.S.

First Name & Middle Initial & Last Name & Degree

Carolyn K McCourt, M.D.

First Name & Middle Initial & Last Name & Degree

Dineo Khabele, M.D.

First Name & Middle Initial & Last Name & Degree

Esther Lu, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.siteman.wustl.edu

Description

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

Learn more about this trial

Patient-centered Educational Material to Improve Colposcopy Adherence

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