Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glia… (NCT05067049) | Clinical Trial Compass
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Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated
France66 participantsStarted 2019-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.