Barriers to Cervical Cancer Screening | NCT06284447

Studies
Barriers to Cervical Cancer Screening

NCT06284447

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 21, 2025Actual

Enrollment

2,216Actual

Phase

Not provided

Conditions

Cervical Carcinoma

Interventions

Non-Interventional Study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2024-00181	Registry Identifier	CTRP (Clinical Trial Reporting Program)
22-004500	Other Identifier	Mayo Clinic Institutional Review Board

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 23, 2023Actual

Primary Completion Date

Oct 28, 2023Actual

Completion Date

Oct 28, 2023Actual

First Submitted Date

Feb 22, 2024

First Submission Date that Met QC Criteria

Feb 28, 2024

First Posted Date

Feb 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2025

Last Update Posted Date

May 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates barriers to cervical cancer screening among non-compliant women.

Detailed Description

PRIMARY OBJECTIVE:

I. To further identify barriers to cervical cancer screening in women, we will identify non-compliant patients and survey them to better understand barriers that have led to inadequate screening.

OUTLINE: This is an observational study.

Participants complete a survey on study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,216Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observational		Participants complete a survey on study.	Other: Non-Interventional Study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional Study	Other	Non interventional study	Observational

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Identify barriers to cervical cancer screening	Participants will receive a brief "Pap Smear Barriers Survey" (likely completed in 5-15 minutes) which asks yes/no/no preference questions regarding potential barriers to cervical cancer screening. Responses will be compared regionally and by Mayo Clinic Health System site.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women between the ages of 21-65
Non-compliant for cervical cancer screening within Mayo Clinic Primary Care

Exclusion Criteria:

Women less than 21 or older than 65
Complaint for cervical cancer screening within Mayo Clinic Primary Care
Women who decline participation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Women aged 21-65 that are non-compliant for cervical cancer screening within the Mayo Clinic Health System

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brittany A. Strelow, DSMc, PA-C	Mayo Clinic in Rochester	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Rochester		Rochester	Minnesota	55905	United States

Label	URL
Mayo Clinic Clinical Trials	View source

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided