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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens
NOT_YET_RECRUITING
Amiens
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Lyon
NOT_YET_RECRUITING
Lyon
Hôpital de la Timone
NOT_YET_RECRUITING
Marseille
Institut régional du Cancer de Montpellier
RECRUITING
Montpellier
CHU Nancy
NOT_YET_RECRUITING
Nancy
CHU Nîmes
NOT_YET_RECRUITING
Nîmes
Institut Claudius Régaud
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Aurore MOUSSION
Aurore.Moussion@icm.unicancer.fr
467612446
Time Frame
Start Date: 2024-07-05
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 187
Treatments
Experimental: Intervention group
Study therapy will include a mixed intervention by a neuropsychologist and a program based on a digital tool
No_intervention: Control group
Usual management of the cognitive complaint according to the habits of center
Related Therapeutic Areas
Sponsors
Leads: Institut du Cancer de Montpellier - Val d'Aurelle

This content was sourced from clinicaltrials.gov