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

Glioma, Malignant Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Diffuse Low-Grade Gliomas (DLGG) are rare tumors that affect young subjects (median age at diagnosis 38 years for grade 2 and 49 for grade 3). Overall survival varies from 5 to 15 years. Cognitive symptoms are common in these patients, notably impaired memory, attention and executive functions. For examples, in a prospective study conducted by our team, 40-53% of patients with grade 2 DLGG starting first-line chemotherapy had a cognitive complaint. These findings are in line with a recent meta-analysis based on 11 studies involving 313 glioma patients. These cognitive disorders can have a deleterious impact on patients' professional, family and social lives, and have a negative impact on their quality of life. The value of cognitive rehabilitation has been demonstrated in other neurological pathologies. Randomized controlled trials in DLGG are promising, but are ultimately few in number and/or have significant limitations (e.g. small number of patients, sample heterogeneity, questionable matching criteria, lack of control group). Furthermore, due to limited access to rehabilitation by neuropsychologists, some studies have evaluated the impact of digital cognitive rehabilitation programs. Although this type of tool seems particularly well suited to this young patient population, it cannot replace human accompaniment by a neuropsychologist. Indeed, we know the importance of the patient's human therapeutic alliance for adherence to a program. Moreover, certain psychopathological variables (e.g. anxiety, depression) have a significant impact on both neurocognitive abilities and complaints, justifying the intervention of a neuropsychologist specialized in oncology. ;

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

• NCT number: NCT06468176
• Study type: Interventional
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Aurore MOUSSION
• Phone: 0467612446
• Email: Aurore.Moussion@icm.unicancer.fr
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Completion date: December 15, 2027