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

NCT06468176 | Recruiting

• 1 other identifier: PROICM 2023-06 FRE
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Glioma, Malignant

Keywords

Oncology; Neurologic Disorder; Neuropsychological rehabilitation; Diffuse Glioma

Outcome Measures

Primary Outcomes (1)

• Score in the Perceived Cognitive Impairment (PCI) subscale of Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire

  The FACT-Cog is a self-assessment questionnaire to estimate memory, attention, concentration, language, and thinking abilities of patients before, during, and after chemotherapy. This questionnaire, composed of 37 items consists of four subscales: cognitive impairments perceived by the patient (20 items), comments from others (4 items), cognitive abilities perceived by the patient (9items), and impact on quality of life (4 items). The Perceived Cognitive Impairments and the Comments from Others subscales are rated on 5-point Likert-type scale (from 0 = "Never" to 4 = "Several times a day"). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate perceived cognitive abilities and the impact on quality of life. For all subscales, a higher score represents better cognitive functioning or quality of life

  4 months

Secondary Outcomes (24)

• Score in the PCI subscale of FACT-Cog questionnaire

  6, 12 and 18 months

• Score in the " Comments from the others " subscale of the FACT-Cog

  At baseline, 4, 6, 12 and 18 months

• Score in the " Cognitive abilities perceived by the patient " subscale of the FACT-Cog

  At baseline, 4 months, 6 months, 12 months, 18 months

• Score in the " Impact on quality of life " subscale of the FACT-Cog

  At baseline, 4 months, 6 months, 12 months, 18 months

• FACT-Cog cognitive complaints questionnaire and the main neurocognitive domains

  At baseline, 4 months and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Study therapy will include a mixed intervention by a neuropsychologist and a program based on a digital tool

Other: Cognitive Behavioral Therapy (CBT) neuropsychologist

Control group

NO INTERVENTION

Usual management of the cognitive complaint according to the habits of center

Interventions

Cognitive Behavioral Therapy (CBT) neuropsychologist OTHER

* CBT: at least 3 teleconsultations by the neuropsychologist (up to 1/week maximum) * Brain Head Quarters (BrainHQ) Digital program: 4 sessions of 40 minutes / week

Also known as: digital program

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ;
• 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 ;

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (8)

Institut régional du Cancer de Montpellier

Montpellier, Hérault, 34298, 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, 31059, France

NOT YET RECRUITING

Related Publications (1)

• Guerdoux E, Coutant L, Gourgou S, Mollevi C, Duc MS, Salasc F, Duffau H, Darlix A. Efficacy of hybrid remote neuropsychological rehabilitation on cognitive complaints in post-therapeutic lower-grade glioma: the FREEDOME randomized study protocol. Front Psychol. 2025 Sep 23;16:1650861. doi: 10.3389/fpsyg.2025.1650861. eCollection 2025.

  PMID: 41064168 DERIVED

MeSH Terms

Conditions

Glioma; Neoplasms; Nervous System Diseases

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amelie DARLIX, MD

  Institut de Cancérologie de Montpellier (ICM)

  STUDY CHAIR

• Estelle GUERDOUX, PHD

  Institut de Cancérologie de Montpellier (ICM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore MOUSSION

CONTACT

467612446; Aurore.Moussion@icm.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 21, 2024
• Study Start: July 5, 2024
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (8)