Linguistically-Tailored Mobile Intervention for the Improvement of Follow Up for Abnormal Pap Test Results

Not Applicable

Completed

• Conditions: Cervical Carcinoma
• Interventions: Other: Health Promotion and Education; Other: Survey Administration; Other: Interview

• Registration Number: NCT04821297
• Lead Sponsor: Thomas Jefferson University

Brief Summary

This clinical trial evaluates the feasibility of a linguistically-tailored mobile intervention, called CervixChat in improving the follow-up of patients with abnormal Papanicolaou (pap) test results. A text messaging program, such as CervixChat may support patients who need a colposcopy.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility of CervixChat intervention in a mix method design, through participants consent rate and the study completion rate.

SECONDARY OBJECTIVE:

I. To evaluate the acceptability of CervixChat intervention using a validated Likert-scale participant satisfaction questionnaire, as well as participant's interview data.

EXPLORATORY OBJECTIVE:

I. To evaluate the preliminary impact of CervixChat intervention, by comparing the colposcopy appointment adherence rate in the study cohort against a 1:1 matched control sample selected based on matching age, race and ethnicity, from participants at Jefferson Obstetrics and Gynecology (Ob-Gyn) department scheduled for a colposcopy in 2019.

OUTLINE:

Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy.

After completion of study, patients are followed up periodically.

Study Timeline

• Study Start: 2021-02-18
• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-29
• Primary Completion: 2021-08-31
• Study Completion: 2021-09-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Female, aged 21 to 65 years of age
• Had received an abnormal Pap smear result
• Scheduled colposcopy
• Able to communicate with ease in English or Spanish
• Have a cell phone with text (TXT) ability
• Competent to give consent

Exclusion Criteria

• Are pregnant at the time of recruitment
• Display current evidence of positive invasive carcinoma of the cervix

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (message)	Health Promotion and Education	Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy.
Supportive care (message)	Interview	Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy.
Supportive care (message)	Survey Administration	Patients receive text messages for 1-2 months before scheduled appointment. Patients also complete a survey at baseline and after standard of care colposcopy and an interview after standard of care colposcopy.

Primary Outcome Measures

Name	Time	Method
Patient Consent Rate	Up to 12 months
Study Completion Rate	Up to 12 months

Trial Locations

Locations (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States