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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-05

Study Completion Date

2027-12-15

Brief Summary

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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

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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.

Conditions

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Glioma, Malignant

Keywords

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Oncology Neurologic Disorder Neuropsychological rehabilitation Diffuse Glioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT) neuropsychologist

Intervention Type 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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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digital program

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amelie DARLIX, MD

Role: STUDY_CHAIR

Institut de Cancérologie de Montpellier (ICM)

Estelle GUERDOUX, PHD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Montpellier (ICM)

Locations

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Institut régional du Cancer de Montpellier

Montpellier, Hérault, France

Site Status RECRUITING