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

Thomas Jefferson University

Status: Completed

Conditions: Cervical Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04821297

20D.1271

JT 16196 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Supportive care (message)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Health Promotion and Education

Other: Survey Administration