About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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) ;
Trial design
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy (CBT) neuropsychologist
Other intervention* 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
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Score in the PCI subscale of 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.
Score in the " Comments from the others " subscale of the FACT-Cog
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 including comments from other (4 items). This subscale is rated on 5-point Likert-type scale (from 0 = "Never" to 4 = "Several times a day"). A higher score represents better cognitive functioning or quality of life.
Score in the " Cognitive abilities perceived by the patient " subscale of the FACT-Cog
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 including cognitive abilities perceived by the patient (9 items). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate perceived cognitive abilities. A higher score represents better cognitive functioning or quality of life.
Score in the " Impact on quality of life " subscale of the FACT-Cog
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 including impact on quality of life (4 items). An intensity 5-point Likert-type scale (from 0 "Not at all" to 4 "Very much") is used to rate the impact on quality of life. A higher score represents better cognitive functioning or quality of life.
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