Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated (TELEGLIO)

Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated: a Prospective, Randomized Study

This study is to evaluate the efficacy of a mobile app for monitoring the quality of life of patients but also on detection delay of side effects and/or complications linked to the therapeutic management. This allow to adapt their care more quickly, through a prospective randomized study. The impact of this connected monitoring of patients' anxiety will also be evaluated in this study as well as the time taken by the medical team to manage alerts generated by this application.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Phone Use, Cell; Glial Scar
• Intervention / Treatment: Device: Connected application arm; Device: Unconnected arm

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie-Hélène barba

Study Locations

• France
  • Marseille, France, 13009
    • Recruiting
    • Clinique privée
    • Contact: Jean-François Oudet; Email: jf.oudet@ecten.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female over 18 years old without upper age limit.
• Subject operated for a non-recurrent glioma (grade II or III or IV glioma / glioblastoma) according to the WHO classification 2016;
• Subject with a connected support (smartphone,...) to download the connected tracking application.
• Unprotected adult within the meaning of the law
• Subject affiliated to a health insurance scheme
• Subject having signed an informed written consent

Exclusion Criteria:

• Minor subject, pregnant or breastfeeding woman;
• Subject under a measure of legal protection, guardianship or deprived of liberty by judicial or administrative decision;
• Antipsychotic treatment (neuroleptic or lithium)
• Subjects with documented cognitive disorders (Alzheimer, other dementia)
• Subject with a personal medical history of psychiatry
• Subject unable to complete a questionnaire on his own (inability to read French language , severe cognitive disorders)
• Medical contraindication to performing an MRI (pace-maker) or scanner;
• Subject refusing to sign informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...); The patients in this arm will have connected mobile app at home and they will regularly fill questionnaires. There are two different questionnaires : one with 14 questions about patient's quality of life and about the evolution of his surgical scar. One with 9 questions only about quality of life. They will also have meetings with physicians.	Device: Connected application arm; patients have to respond different questionnaires about their quality of life on the mobile app. And follow-up visits with the physicians as usual
Other: No QoL online follow-up arm; The patient haven't any questionnaires to fill at home. This is the normal management of the pathology. They only have different meeting with the specialist,as usual.	Device: Unconnected arm; Follow-up visits with the pysicians as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the impact of the connected mobile monitoring application on the quality of life, at 6 months, of patients treated for an operated glioma.	The primary outcome measure is the difference in quality of life assessed by the QLQ-BN20 scale at 6 months, compared to inclusion. This scale is made up of 20 items which are grouped into 4 dimensions (future uncertainty, visual disorder, motor dysfunction, and communication deficit) and 7 isolated items.	6 months

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Clairval Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Gliosis
• Other Study ID Numbers: 2018-A03009-46

Drug and device information, study documents

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