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

Starting soon · Not applicable

Conditions studied: Oncology, Glioma

In brief

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. The 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.

Key facts

Study ID

NCT07439302

Run by

Assistance Publique - Hôpitaux de Paris

People needed

80

Starts

2026-09-01

Expected to finish

2029-09-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults (over 18 years of age)
• Written consent from the patient to participate in the clinical study
• Diagnosed with grade 2-4 glioma with IDH1/2 mutation
• Plan to initiate new systemic treatment for glioma (chemotherapy, targeted therapy, or other investigational antitumor systemic agent)
• Candidate for ePRO monitoring using Resilience PRO medical device according to local investigator decision
• Social security coverage

You may not qualify if…

• Severe language impairment
• Cognitive deficit preventing the understanding of essential elements for questionnaires
• Patient under guardianship or curatorship

Where it is running

• Service de Neuro-oncologie, Hôpital de la Pitié-Salpêtrière — Paris, France

Full record on ClinicalTrials.gov

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