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

NCT07439302 | Not Yet Recruiting

• 1 other identifier: APHP251361
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oncology; Glioma

Keywords

oncology; Glioma; quality of life; Resilience Pro application

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  12 months

Secondary Outcomes (7)

• assess the following outcomes in IDH-mutant gliomas patients in real-world conditions treated with systemic treatment:

  12 months

• QOL score deterioration ≥ 5 points using the QLQ-C30 questionnaire

  12 months

• Time to QOL score deterioration

  12 months

• Time to severe adverse events

  12 months

• Time to KPS deterioration

  12 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Neurocognitive assessment and quality of life using Résilience Pro app

Behavioral: Neurocognitive assessment; Other: Questionnaries QoL; Device: Resilience Pro Application

Interventions

Questionnaries QoL OTHER

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

Experimental Arm

Resilience Pro Application DEVICE

Remote monitoring using Resilience Pro Application for QoL questionnaries

Experimental Arm

Neurocognitive assessment BEHAVIORAL

* 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)

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Neuro-oncologie, Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Neoplasms; Glioma

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Mehdi TOUAT, MD

CONTACT

0142160385; mehdi.touat@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with grade 2-4 IDH-mutated glioma diagnosis who will initiate a systemic treatment (chemotherapy, targeted therapy, or other investigational antitumor systemic agent) and who are candidate for ePRO monitoring using Resilience PRO medical device.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)