Evaluation of the Impact of a Connected Application on the Follow-up of Patients Treated for Glial Lesions Operated: a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Connected application arm (Device)
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.
干预措施: Unconnected arm (Device)
结局指标
主要结局
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.
时间窗: 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.
次要结局
未报告次要终点