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NCT04821297 Clinical Trial

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

Cervical Carcinoma Clinical Trial

Official title:
An Innovative and Linguistically-Tailored Mobile Intervention to Improve Follow-Up for Abnormal Pap Test Results: CervixChat

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04821297
Other study ID # 20D.1271
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 18, 2021
Est. completion date September 10, 2021

Study information
Verified date December 2022
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date September 10, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Health Promotion and Education
Receive messages
• Survey Administration
Complete survey
• Interview
Participate in an interview

Locations
Country Name City State
United States Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Consent Rate Up to 12 months
Primary Study Completion Rate Up to 12 months
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