Cognitive rehabilitation program for patients with diffuse glioma

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

This study is testing a new online brain training program to see if it can help people with diffuse glioma improve their memory and thinking skills after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 187 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Montpellier, Hérault and 7 other locations)
• Trial ID: NCT06468176 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of a mixed distance neuropsychological rehabilitation program specifically designed for patients diagnosed with grade 2 or 3 diffuse glioma. The program aims to address cognitive impairments such as memory, attention, and executive function disorders that significantly affect the quality of life of these patients. Participants will receive Cognitive Behavioral Therapy (CBT) from a neuropsychologist, combining digital tools with human support to enhance adherence and therapeutic outcomes. The study includes patients who have undergone neurosurgical excision and have completed any oncological treatments at least six months prior.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histo-molecular diagnosis of grade 2 or 3 diffuse glioma and cognitive complaints.

Not a fit: Patients who are not fluent in French or those who have not undergone neurosurgical excision may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve cognitive function and overall quality of life for patients with diffuse glioma.

How similar studies have performed: Previous studies have shown promising results for cognitive rehabilitation in similar neurological conditions, although this specific approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Montpellier, Hérault and 7 other locations

• Institut régional du Cancer de Montpellier — Montpellier, Hérault, France (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)

Study contacts

• Principal investigator: Estelle GUERDOUX, PHD — Institut de Cancérologie de Montpellier (ICM)
• Study coordinator: Aurore MOUSSION

Conditions Glioma, Malignant; Oncology; Neurologic Disorder; Neuropsychological rehabilitation; Diffuse Glioma