Glial Scar, Phone Use, Cell, Quality of Life
Conditions
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.
Interventions
DEVICEConnected 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
DEVICEUnconnected arm
Follow-up visits with the pysicians as usual
Sponsors
Clairval Hospital
Ramsay Générale de Santé
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactJean-François oudet
Backup ContactMarie-Hélène barba
Outcome results
None listed