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

Germ Cell Tumor Clinical Trial

— TEXTIS  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868176
• Other study ID #: P/2018/404
• Status: Recruiting
• Start date: February 28, 2019
• Est. completion date: August 2021

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Elise ROBERT
• Phone: +381479999
• Email: e1robert[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 235
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Compliance, Patient
• Follow-up
• Germ Cell Tumor
• Neoplasms, Germ Cell and Embryonal
• Text Messaging

Intervention

Other:
• short message service
short message service

Locations

Country	Name	City	State
France	CHU Besancon	Besançon	Franche-Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	biological recurrence rate	Biological recurrence rate is defined by the increase in tumor markers (alpha-fetoprotein, lactic dehydrogenase, human chorionic gonadotropin).	1 year
Secondary	Radiological recurrence rate	Radiological recurrence rate is defined according to Response evaluation criteria in solid tumors (RECIST) criteria 1.1.	1 year