Cognitive rehabilitation program for patients with diffuse glioma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Estelle GUERDOUX, PHD — Institut de Cancérologie de Montpellier (ICM)
• Study coordinator: Aurore MOUSSION
• Email: Aurore.Moussion@icm.unicancer.fr
• Phone: 467612446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.