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

Not Applicable

• Conditions: Quality of Life; Phone Use, Cell; Glial Scar
• Interventions: Device: Unconnected arm; Device: Connected application arm

• Registration Number: NCT05067049
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2021-09-10
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-04
• Last Update Posted: 2021-10-04
• Primary Completion: 2022-02
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No QoL online follow-up arm	Unconnected 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.
Connected EORTC-C30 arm (quality of life questionnaires on pad, phone,...)	Connected application arm	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.

Primary Outcome Measures

Name	Time	Method
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.	6 months	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.

Trial Locations

Locations (1)

Clinique privée; 🇫🇷 Marseille, France