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

Launched by INSTITUT DU CANCER DE MONTPELLIER - VAL D'AURELLE · Jun 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special rehabilitation program designed to help patients with grade 2 or 3 diffuse glioma, which are types of brain tumors. These tumors often cause problems with thinking, memory, and attention, which can affect everyday life, work, and relationships. The goal of the study is to see if a combination of in-person and digital cognitive rehabilitation can improve these cognitive issues and enhance the quality of life for patients.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of grade 2 or 3 diffuse glioma. They should have had surgery for their tumor at least a year ago and be in good overall health. Participants will need to be able to use digital tools, like a computer or tablet, and be fluent in French. Throughout the study, patients can expect to engage in a mixed rehabilitation program that includes both online activities and support, which may help them feel better and improve their cognitive skills. It’s important to note that this study is currently recruiting participants, and the support of healthcare professionals will be involved in the process.

Gender

ALL

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.