Clinical trial NCT06468176: Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients with Grade 2 or 3 Diffuse Glioma
Official title: Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients with Grade 2 or 3 Diffuse Glioma : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma, Malignant
Keywords: Oncology
Neurologic Disorder
Neuropsychological rehabilitation
Diffuse Glioma
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

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.

Primary outcomes:
measure: Score in the Perceived Cognitive Impairment (PCI) subscale of Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire
timeFrame: 4 months
Secondary outcomes:
measure: Score in the PCI subscale of FACT-Cog questionnaire
timeFrame: 6, 12 and 18 months
measure: Score in the " Comments from the others " subscale of the FACT-Cog
timeFrame: At baseline, 4, 6, 12 and 18 months
measure: Score in the " Cognitive abilities perceived by the patient " subscale of the FACT-Cog
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Score in the " Impact on quality of life " subscale of the FACT-Cog
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: FACT-Cog cognitive complaints questionnaire and the main neurocognitive domains
timeFrame: At baseline, 4 months and 12 months
measure: Score in the 2 scales of Prospective and Retrospective Memory Questionnaire (PRMQ) for patient and family caregiver
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on psychopathological distress via Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on quality of life questionnaire Quality of Life Questionnaire - Core (30EORTC QLQ-C30)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on quality of life questionnaire Quality of Life Questionnaire - Brain Neoplasm (EORTC QLQ-BN20)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on fatigue via Multidimensional Fatigue Inventory (MFI-20)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Compliance of intervention
timeFrame: 4 months
measure: Difference in score on neurocognitive test via Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline and 4 and 12 months, respectively
measure: 2 scores on the Prospective and Retrospective Memory Questionnaire (PRMQ) and the main cognitive domains
timeFrame: At baseline, 4 months and 12 months
measure: Proportion of patients returning to work
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on depression via Beck Depression Inventory II (BDI-II)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on anxiety via State-Trait Anxiety Inventory (STAI-Y)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on irritability via Brief Irritability Test (BIT) for patient and family caregiver
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on insomnia via Insomnia Severity Index (ISI)
timeFrame: At baseline, 4 months, 6 months, 12 months, 18 months
measure: Difference in score on cognitive abilities index via Wechsler Adult Intelligent Scale (WAIS-IV)
timeFrame: At Baseline, 4 months, 12 months
measure: Difference in score on verbal learning and memory via Hopkins Verbal Learning Test (HVLT)
timeFrame: At Baseline, 4 months, 12 months
measure: Difference in score on processing speed and executive function via Stroop Delis-Kaplan test
timeFrame: At Baseline, 4 months, 12 months
measure: Difference in score on verbal fluency via verbal fluency test
timeFrame: At Baseline, 4 months, 12 months
measure: Difference in score on visual attention via Trail Making Test (TMT)
timeFrame: At Baseline, 4 months, 12 months
measure: Difference in score on Theory of Mind via Reading the Mind in the Eyes Test (RMET)
timeFrame: At Baseline, 4 months, 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
state: Hérault
city: Amiens
country: France
facility: CHU Amiens
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lyon
country: France
facility: CHU Lyon
city: Marseille
country: France
facility: Hôpital de la Timone
city: Nancy
country: France
facility: CHU Nancy
city: Nîmes
country: France
facility: CHU Nîmes
city: Toulouse
country: France
facility: Institut Claudius Régaud
Study officials:
affiliation: Institut de Cancérologie de Montpellier (ICM)
name: Amelie DARLIX, MD
role: STUDY_CHAIR
affiliation: Institut de Cancérologie de Montpellier (ICM)
name: Estelle GUERDOUX, PHD
role: PRINCIPAL_INVESTIGATOR
References: