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

NCT04821297 | Completed

• 2 other identifiers: 20D.1271JT 16196
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Carcinoma

Outcome Measures

Primary Outcomes (2)

• Patient Consent Rate

  Up to 12 months

• Study Completion Rate

  Up to 12 months

Study Arms (1)

Supportive care (message)

EXPERIMENTAL

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.

Other: Health Promotion and Education; Other: Survey Administration; Other: Interview

Interventions

Health Promotion and Education OTHER

Receive messages

Supportive care (message)

Survey Administration OTHER

Complete survey

Supportive care (message)

Interview OTHER

Participate in an interview

Supportive care (message)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Health Promotion; Educational Status; Interviews as Topic

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: February 18, 2021
• Primary Completion: August 31, 2021
• Study Completion: September 10, 2021
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)