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RECRUITING

NCT06468176

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

Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

View on ClinicalTrials.gov

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.

Official title: Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma : a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2024-07-05

Completion Date

2027-12-15

Last Updated

2025-12-19

Healthy Volunteers

Conditions

Glioma, Malignant

Interventions

OTHER

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

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.

Locations (8)

Institut régional du Cancer de Montpellier

Montpellier, Hérault, France

CHU Amiens

Amiens, France

CHU Bordeaux

Bordeaux, France

CHU Lyon

Lyon, France

Hôpital de la Timone

Marseille, France

CHU Nancy

Nancy, France

CHU Nîmes

Nîmes, France

Institut Claudius Régaud

Toulouse, France