NCT04070534

Brief Summary

In this study, the researchers will utilize information gained from patient interviews about their knowledge of the cervical cancer screening and treatment process, and perceived barriers surrounding appropriate follow up, to create content for the intervention.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Aug 2019Dec 2026

Study Start

First participant enrolled

August 22, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

6.8 years

First QC Date

August 23, 2019

Last Update Submit

August 11, 2025

Conditions

Health Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (2)

  • Reusable knowledge objects (RKOs)

    Knowledge of cervical cancer screening and treatment, and perceived barriers, as measured in qualitative interviews

    Month 1-2

  • Knowledge change

    Quantitative change in knowledge post-intervention, as measured by attendance rates at follow-up visits

    Month 3-4

Study Arms (1)

PALS intervention

OTHER

This arm will influence the development of a patient-directed education module using the Patient Activated Learning System (PALS)

Other: PALS

Interventions

PALSOTHER

patient activated learning system

PALS intervention

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Women 21-65 years with diagnosis of abnormal pap smear presenting to Women's Health Colposcopy Clinic at WCMC
  • Access to a smartphone
  • English or Spanish Speaking

You may not qualify if:

  • Pregnant women
  • Non-English or Spanish speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Prebyterian Hospital Weill Cornell

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Eloise Chapman-Davis, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

August 22, 2019

Primary Completion (Estimated)

June 4, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)