[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626720":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":32,"locations":39,"responsibleParty":54,"collaborators":22,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":22,"enrollmentInfo":66,"targetDuration":22,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":80,"whyStopped":22,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Arm","EXPERIMENTAL","Neurocognitive assessment and quality of life using Résilience Pro app",[13,14,15],"Behavioral: Neurocognitive assessment","Other: Questionnaries QoL","Device: Resilience Pro Application",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"BEHAVIORAL","Neurocognitive assessment","* Memory:\n\n  * RL-RI 16 test (the French version of the Free and Cued Recall Test)\n  * Recall after 3 minutes of the Rey Complex Figure Test\n  * Digits forward (verbal\u002Fvisual) WAIS III\n* Working memory:\n\n  * Letter - number sequencing\n  * Digits backward (verbal\u002Fvisual) WAIS III\n* Language:\n\n  * Short-Boston Naming test , for which normative data are in course of validation\n  * Token test\n* Visuo-spatial ability:\n\n  \\- Copy subtest of the Rey Complex Figure Test\n* Cognitive executive functions:\n\n  * Stroop test\n  * Semantic fluency test\n  * Letter fluency test\n* Behavioural executive functions:\n\n  * ISDC (Dysexecutive questionnaire)",[9],null,{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Questionnaries QoL","Questionnaires QLQ-C30 and EQ-5D-5L filled on the Resilience app Questionnaires FACT-Br and QLQ BN20 filled on paper forms",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"DEVICE","Resilience Pro Application","Remote monitoring using Resilience Pro Application for QoL questionnaries",[9],[33],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Mehdi TOUAT, MD","CONTACT","0142160385","+33","mehdi.touat@aphp.fr",[40],{"facility":41,"status":22,"city":42,"state":22,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Service de Neuro-oncologie, Hôpital de la Pitié-Salpêtrière","Paris","75013","France","FR",{"type":47,"coordinates":48},"Point",[49,50],2.3488,48.85341,{"lat":50,"lon":49},[53],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},{"type":55,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100626720","monitoring-of-neurological-symptoms-treatment-tolerance-and-quality-of-life-using-the-resilience-pro-electronic-patient-reported-outcome-application-in-patients-with-idh-mutated-glioma-100626720",false,"NCT07439302","Monitoring of Neurological Symptoms, Treatment Tolerance, and Quality of Life Using the Resilience PRO Electronic Patient-reported Outcome Application in Patients With IDH-mutated Glioma","A Prospective Multi-center Study to Monitor Neurological Symptoms, Treatment Tolerance, and Quality of Life Using the Resilience PRO Electronic Patient-reported Outcome Application in Patients With IDH-mutated Glioma","NEURO-PRO-GLIO","Inclusion Criteria:\n\n1. Adults (over 18 years of age)\n2. Written consent from the patient to participate in the clinical study\n3. Diagnosed with grade 2-4 glioma with IDH1\u002F2 mutation\n4. Plan to initiate new systemic treatment for glioma (chemotherapy, targeted therapy, or other investigational antitumor systemic agent)\n5. Candidate for ePRO monitoring using Resilience PRO medical device according to local investigator decision\n6. Social security coverage\n\nExclusion Criteria:\n\n1. Severe language impairment\n2. Cognitive deficit preventing the understanding of essential elements for questionnaires\n3. Patient under guardianship or curatorship","ALL","18 Years",{"count":67,"type":68},80,"ESTIMATED","INTERVENTIONAL",[71],"NA","Patients with IDH-mutant glioma frequently experience symptoms such as fatigue, seizures, headaches, cognitive impairments (primarily attentional), and mood changes, which can significantly affect their health-related quality of life (HRQoL). Disease progression and treatment-related toxicities are the two primary factors driving the decline in HRQoL in this population. These symptoms can be exacerbated by side effects from available therapeutic options, such as chemotherapy, radiation therapy, or targeted IDH inhibitors. In this context, it is crucial to consider the combined effects of these treatments on patient symptoms and HRQoL. Given that this population is young and otherwise healthy, with long-term survival exceeding 10 years after diagnosis, it is essential to consider not only on longevity but also on overall functioning and HRQoL when making treatment decisions. Assessing quality of life has therefore become a key parameter in phase III clinical trials and observational studies under real-world conditions.\n\nThe Resilience PRO digital medical device (DMD; CE-marked class IIa) enables remote monitoring of patients treated for cancer who are receiving systemic therapy. Resilience PRO has been positively evaluated by the French National Health Authority (HAS) and included on the LATM list under its brand name. Resilience PRO sends validated weekly questionnaires to patients (NCI PRO-CTCAE ePatient Reported Outcomes \\[ePROs\\]), inquiring about treatment- and disease-related symptomatic adverse events. The associated alert algorithm, equivalent to those used in the STAR and PRO-TECT studies, allows for the proactive management of severe or worsening symptoms by the healthcare professional receiving the alert. Additionally, Resilience PRO provides patients with personalized access to a mobile app that offers resources aimed at improving education, self-management, and patient engagement. These innovations lead to clinical benefits (improved quality of life, reduced morbidity, and increased overall survival), as well as organizational benefits (reduced emergency room visits and hospitalizations) and economic advantages.",[74,75],"Oncology","Glioma",[77,75,78,79],"oncology","quality of life","Resilience Pro application","NOT_YET_RECRUITING","2026-02-23",{"date":83,"type":84},"2026-02-27","ACTUAL",{"date":86,"type":68},"2026-09",{"date":88,"type":68},"2029-09",{"name":5,"class":6},1]