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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06468176
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Amelie DARLIX, MDEstelle GUERDOUX, PHD
Principal Investigator Affiliation	Institut de Cancérologie de Montpellier (ICM)Institut de Cancérologie de Montpellier (ICM)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Malignant

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Other: - Cognitive Behavioral Therapy (CBT) neuropsychologist

- 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

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