Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma

NCT06468176 · tracked via the Priya Life Science France tracker

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Phase

Not applicable

Started

2024-07-05

Last updated

2025-12-19

Condition(s) studied

Glioma, Malignant

Investigational drug(s) / intervention(s)

Cognitive Behavioral Therapy (CBT) neuropsychologist

Cognitive Behavioral Therapy (CBT) neuropsychologist: * CBT: at least 3 teleconsultations by the neuropsychologist (up to 1/week maximum) * Brain Head Quarters (BrainHQ) Digital program: 4 sessions of 40 minutes / week

Study summary

Diffuse low-grade glioma are rare brain tumors affecting young subjects (median age at diagnosis 38 years for grade 2 and 49 years for grade 3). Cognitive symptoms are common in these patients, including memory, attention and executive function disorders. These disorders may have a deleterious impact on patients' professional, family and social lives, and have a negative impact on their quality of life. The benefits of cognitive rehabilitation have been demonstrated in other neurological pathologies. Furthermore, due to limited access to rehabilitation by neuropsychologists, some studies have evaluated the impact of digital cognitive rehabilitation programs. However, it cannot replace human support.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥18 years old, no age limit; * Histo-molecular diagnosis of grade 2 or 3 diffuse glioma according to World Health Organization (WHO) Classification 2016, regardless of oncological treatments previously received; * Patient in satisfactory general condition for the study, defined by a WHO performance index ≤ 2 (ECOG-Performance Status (PS) ≤ 2); * Neurosurgical excision (excluding biopsy) performed ≥ 12 months previously; * In the case of oncological treatment, patient who has completed his sessions (radiotherapy, chemotherapy) for ≥ 6 months; * Patient presenting a cognitive complaint defined as a response rated at least "Fairly" to at least one of the 2 items (n°20 and 25) assessing cognitive complaint in the EORTC QLQ-C30 questionnaire (i.e., defined as a score on the "Cognitive Functioning" scale ≤ 66.67); * Fluent in French; * Affiliation to the French Social Security System; * Possible regular use of a digital tool with Internet access; * Signature of informed consent prior to any study procedure. Exclusion Criteria: * Visual or auditory deficit not corrected to normal and/or preventing use of computer tools (i.e., homonymous lateral hemianopia is not a criterion for non-inclusion) ; * Concurrent participation in a study with cognition as primary endpoint (e.g., "POLCA", " POLO " clinical trials) ; * Legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent form or completing the study ; * Unstable or uncontrolled psychiatric syndrome (i.e., psychotropic treatments are not a criterion for non-inclusion if doses are stable) ; * Known severe cognitive impairment (e.g., neurodegenerative disease, sequelae of head trauma, etc.) or defined by a score ≤ 20 on the MoCA test or impacting the ability to use digital tools at home ; * Oncological treatment (radiotherapy and/or chemotherapy and/or surgery) planned within 4 months of inclusion. Targeted anti-Isocitrate DeHydrogenase (IDH) therapies are authorized.

Primary outcome measure(s)

Score in the Perceived Cognitive Impairment (PCI) subscale of Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire — 4 months
The FACT-Cog is a self-assessment questionnaire to estimate memory, attention, concentration, language, and thinking abilities of patients before, during, and after chemotherapy. This questionnaire, composed of 37 items consists of four subscales: cognitive impairments perceived by the patient (20 items), comments from others (4 items), cognitive abilities perceived by the patient (9items), and impact on quality of life (4 items). The Perceived Cognitive Impairments and the Comments from Others subscales are rated on 5-point Likert-type scale (from 0 = "Never" to 4 = "Several times a day"). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate perceived cognitive abilities and the impact on quality of life. For all subscales, a higher score represents better cognitive functioning or quality of life

Trial sites (8)

Facility	City	Region	Status
Institut régional du Cancer de Montpellier	Montpellier	Hérault	Recruiting
CHU Amiens	Amiens	France	Not Yet Recruiting
CHU Bordeaux	Bordeaux	France	Not Yet Recruiting
CHU Lyon	Lyon	France	Not Yet Recruiting
Hôpital de la Timone	Marseille	France	Not Yet Recruiting
CHU Nancy	Nancy	France	Not Yet Recruiting
CHU Nîmes	Nîmes	France	Not Yet Recruiting
Institut Claudius Régaud	Toulouse	France	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06468176 on ClinicalTrials.gov ↗ ← All trials in France