Neurocognitive Risks in Children With Solid Tumors

Study Overview
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Brief Summary
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The survival rate of children with cancer has improved significantly in recent years thanks to the progress of different therapies. The neurocognitive sequelae related to treatments and illness are more or less well known. Four factors seem to be associated with neurocognitive sequelae: treatment, the tumor itself, environmental factors like the socio-economic status of parents and biological factors. Main purpose of the study is to establish a score to assess the risk of neurocognitive sequelae in these children based on these factors (treatment, tumor, and environmental factors)

Official Title
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Neurocognitive Risks in Children With Solid Tumors

Conditions
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Solid Tumor in Children

Intervention / Treatment
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* Other: The WISC-IV
* Other: The CMS (CHILD MEMORY SCALE)
* Other: CONNERS
* Other: BRIEF
* Other: PEDS-QL
* Other: State Trait Anxiety Inventory
* Other: Child Depression Inventory


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 6 to 16 years and 11 months during the study period (2014-2016) Type of pathology: solid tumor Place of treatment and follow-up: Gustave Roussy Minimum time from the end of the initial treatment: For patients who have not received treatment with methotrexate: 6 months For patients being treated with methotrexate: none Obtaining the non-opposition of parents / legal representatives Affiliation to a social security scheme. Exclusion Criteria: Patients with other pathologies associated with mental retardation (autism, genetic syndrome ...) Patients lost to follow-up Deceased patients Patients treated for a pathology whose prognosis is involved in the very short term (infiltrating glioma of the brainstem, recurrence of the pathology during treatment) Non-French speaking patients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated for a brain tumor<br>As part of their usual follow-up, these patients have neuropsychological evaluations following their treatment. A complete neuropsychological evaluation will therefore be performed as part of their usual follow-up during the inclusion period of this study and only the data from this evaluation will be taken into account for the statistical analysis of this study. | Other: The WISC-IV<br>* The WISC-IV (Weschler, 2003) which is measured with several indices: A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks) A rate of treatment index (RTI) that assesses grapho-motor speed<br>Other: The CMS (CHILD MEMORY SCALE)<br>* It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after)<br>Other: CONNERS<br>* The CONNERS which allows the assessment of attentional skills through a questionnaire that will be completed by parents<br>Other: BRIEF<br>* The BRIEF which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation.<br>Other: PEDS-QL<br>* The PEDS-QL quality of life that will be completed by the parents and the patient concerns the day-to-day functioning of the child (in school, relationships to others, physical abilities and emotional state)<br>Other: State Trait Anxiety Inventory<br>* The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).<br>Other: Child Depression Inventory<br>* The Child Depression Inventory (CDI) assessing any signs of depression in the child.<br>|
| Patients treated for a non-cerebral tumor<br>A single neuropsychological assessment will be proposed to these patients after the end of treatment and during the inclusion period of this study. This evaluation will be carried out during a visit to Gustave Roussy as part of their usual follow-up. If on the occasion of this evaluation, cognitive disorders or psychological disorders were highlighted, a neuropsychological and / or psychological follow-up would be proposed. | Other: The WISC-IV<br>* The WISC-IV (Weschler, 2003) which is measured with several indices: A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks) A rate of treatment index (RTI) that assesses grapho-motor speed<br>Other: The CMS (CHILD MEMORY SCALE)<br>* It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after)<br>Other: CONNERS<br>* The CONNERS which allows the assessment of attentional skills through a questionnaire that will be completed by parents<br>Other: BRIEF<br>* The BRIEF which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation.<br>Other: PEDS-QL<br>* The PEDS-QL quality of life that will be completed by the parents and the patient concerns the day-to-day functioning of the child (in school, relationships to others, physical abilities and emotional state)<br>Other: State Trait Anxiety Inventory<br>* The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).<br>Other: Child Depression Inventory<br>* The Child Depression Inventory (CDI) assessing any signs of depression in the child.<br>|
| Patients who received Methotrexate<br>Methotrexate is used in the treatment of certain brain tumors as in that of non-cerebral tumors. Some of these patients, particularly those who have had neurological complications with methotrexate, will already have longitudinal neuropsychological follow-up as part of their usual follow-up. For these patients, only one complete neuropsychological assessment will be performed during the inclusion period and will be considered for statistical analysis. For patients in the course of treatment with methotrexate, during the period of inclusion of this study, a longitudinal follow-up will be carried out with neuropsychological evaluations close and successive at the time of their coming to Gustave Roussy within the usual framework of their care. | Other: The WISC-IV<br>* The WISC-IV (Weschler, 2003) which is measured with several indices: A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks) A rate of treatment index (RTI) that assesses grapho-motor speed<br>Other: The CMS (CHILD MEMORY SCALE)<br>* It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after)<br>Other: CONNERS<br>* The CONNERS which allows the assessment of attentional skills through a questionnaire that will be completed by parents<br>Other: BRIEF<br>* The BRIEF which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation.<br>Other: PEDS-QL<br>* The PEDS-QL quality of life that will be completed by the parents and the patient concerns the day-to-day functioning of the child (in school, relationships to others, physical abilities and emotional state)<br>Other: State Trait Anxiety Inventory<br>* The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).<br>Other: Child Depression Inventory<br>* The Child Depression Inventory (CDI) assessing any signs of depression in the child.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive analysis of possible neurocognitive deficits according to the pathology and treatments received. |  | Up to 60 months | 
| Univariate analysis to identify risk factors related to cognitive disorders. |  | Up to 60 months | 
| Multiple regression analysis to determine the most significant risk factors and examine the interactions between these factors. |  | Up to 60 months |