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

NCT ID: NCT04821297

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-18
• Study Completion Date: 2021-09-10

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.

Conditions

Cervical Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (message)

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.

Group Type: EXPERIMENTAL

Health Promotion and Education

Intervention Type: OTHER

Receive messages

Survey Administration

Intervention Type: OTHER

Complete survey

Interview

Intervention Type: OTHER

Participate in an interview

Interventions

Health Promotion and Education

Receive messages

Intervention Type: OTHER

Survey Administration

Complete survey

Intervention Type: OTHER

Interview

Participate in an interview

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JT 16196

Identifier Type: OTHER

Identifier Source: secondary_id

20D.1271

Identifier Type: -

Identifier Source: org_study_id