Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors (TEXTIS)

Phase II, Open-label, Randomized, Non-comparative Study Evaluating the Impact of Short Message Service (SMS) on Compliance With Surveillance of Patients With Germ-cell Tumors. (TEXTIS Study)

This study will evaluate the impact of Short Message Service (SMS) on compliance with surveillance of patients with germ-cell tumors. Patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder SMS before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without SMS.

Study Overview

• Status: Unknown
• Conditions: Compliance, Patient; Germ Cell Tumor; Follow-up; Text Messaging
• Intervention / Treatment: Other: short message service

• Study Type: Observational
• Enrollment (Anticipated): 235

Contacts and Locations

• Study Contact: Name: Elise Robert; Phone Number: +381479999; Email: e1robert@chu-besancon.fr

Study Locations

• France
  • Franche-Comté
    • Besançon, Franche-Comté, France, 25030
      • Recruiting
      • CHU Besançon
      • Contact: Elise Robert; Phone Number: +381479999; Email: e1robert@chu-besancon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

235 patients, with 157 in the experimental arm, with SMS sending and 78 patients in the control arm, without sending SMS.

Description

Inclusion Criteria:

• Patient with germ cell tumor.
• Patient with a mobile phone.
• Patient on surveillance.

Exclusion Criteria:

• Testicular cancer without germ cell component.
• Prior history of other malignancy except for: cutaneous cancers excluding melanoma, superficial bladder tumor, localized prostate cancer with undetectable PSA.
• Cognitive condition that would preclude patient's understanding and completion of study procedures.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: reminder SMS before appointment; SMS before appointment detailing the date of consultation and exams to be performed before	Other: short message service; short message service
Active comparator: standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients who report optimal compliance to surveillance	Optimal compliance is defined according to the following 2 parameters: The patient comes to all the appointments, on the expected day, AND; With all the biological and imaging exams previously scheduled by the physician.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients who report intermediate compliance to surveillance	Intermediate compliance is defined according to the following 2 parameters: The patient comes to all the appointments, but in one of the consultations, he delays his scheduled appointment of more than 3 weeks but less than 6 weeks OR; Missing a biological or imaging exam.	1 year
Rate of patients who report a non compliance to surveillance	Non compliance is defined according to the following 3 parameters: The patient misses a consultation, without warning, OR; He delays of more than 6 weeks his appointment of consultation, OR; At least 2 biological or imaging exams requested by the oncologist are missing from all consultations.	1 year
Patient satisfaction of sending SMS, in experimental arm	It is evaluated with the following question: do you find that having reminder sms for your appointments and exams is useful? evaluated on a scale of 0 to 10 (0: useless, 10: useful)	1 year
biological recurrence rate	Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).	1 year
Radiological recurrence rate	Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2019
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (ACTUAL): March 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 7, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: compliance; short message service; surveillance; germ cell tumors
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal
• Other Study ID Numbers: P/2018/404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No