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

Condition(s) studied

Investigational drug(s) / intervention(s)

Neurocognitive assessment: * Memory: * RL-RI 16 test (the French version of the Free and Cued Recall Test) * Recall after 3 minutes of the Rey Complex Figure Test * Digits forward (verbal/visual) WAIS III * Working memory: * Letter - number sequencing * Digits backward (verbal/visual) WAIS III * Language: * Short-Boston Naming test , for which normative data are in course of validation * Token test * Visuo-spatial ability: \- Copy subtest of the Rey Complex Figure Test * Cognitive executive functions: * Stroop test * Semantic fluency test * Letter fluency test * Behavioural executive functions: * ISDC (Dysexecutive questionnaire)

Questionnaries QoL: Questionnaires QLQ-C30 and EQ-5D-5L filled on the Resilience app Questionnaires FACT-Br and QLQ BN20 filled on paper forms

Resilience Pro Application: Remote monitoring using Resilience Pro Application for QoL questionnaries

Study summary

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.

Eligibility

Primary outcome measure(s)

• The primary objective of the study is to assess the quality of life using the QLQ-C30 questionnaire in IDH-mutant gliomas patients in real-world conditions treated with systemic treatment (IDH inhibitor, PCV, TMZ). — 12 months
  QOL scores will be followed every two weeks using the Resilience PRO tool. QOL global score deterioration will be defined as a deterioration with a minimal clinically important difference ≥ 10 points as compared to the baseline score (V1 - M0) . Baseline score evaluation will be performed before the initiation of systemic therapy. Proportion of patient with a QoL score deterioration will be reported at clinically relevant timepoints such as 6 and 12 months.

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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