PALS for Pap Smear Follow up (PALS)

Utilization Of A Web-Based Platform (Patient Activated Learning System- PALS) To Improve Knowledge And Follow-Up Among Women With Abnormal Cervical Cancer Screening (PALS)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: PALS

Detailed Description

The overall goal of this research is to develop and test an intervention designed to improve knowledge and follow up among underserved women with abnormal pap smears. The researchers will use a unique web-based platform, the Patient Activated Learning System (PALS), which provides engaging and informative video and text designed to improve patient knowledge specifically among underserved populations. Twenty diverse patients with abnormal pap smears will be recruited from the Women's Health colposcopy clinic for initial qualitative interviews. Forty patients from the same population will then be engaged in a pre-post pilot to examine feasibility, acceptability, and impact of modules on improving knowledge.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York Prebyterian Hospital Weill Cornell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant women
• Non-English or Spanish speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PALS intervention; This arm will influence the development of a patient-directed education module using the Patient Activated Learning System (PALS)	Other: PALS; patient activated learning system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Eloise Chapman-Davis, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-05020040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No