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Nervous System Neoplasms

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Central Nervous System Diseases

Newly diagnosed brain tumour patients aged between 5 and 13 years

Patients diagnosed with Cystic Fibrosis aged between 5 and 13 years

Healthy children aged between 5 and 13 years

A Kingma, PhD

There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The aim is to study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. If we can identify the specific deficits these patients experience, neuropsychological treatment and guidance can be developed to give patients the most optimal chances to live as normal as possible, to improve their quality of life (QoL) and to prevent them from developing depression and anxiety. Eventually, an intervention programme could be developed based on our results, to improve social, vocational and emotional QoL.

* Rationale: There is ample evidence that children treated for a brain tumour (BT) often develop deficits in social and emotional functioning. The investigators wish to examine the cause of these deficits, i.e. the underlying neuropsychological deficit(s). The following is expected:

  1. Children treated for a BT will perform worse than both healthy controls and patients with Cystic Fibrosis (CF) on measures of social cognition at Time 2 (3 years post diagnosis), but not at Time 1 (shortly after diagnosis, before neurotoxic treatment). The deterioration in performance will be influenced by the following adverse factors:

     1. History of cranial radiation therapy;
     2. Site of lesion in diencephalon;
     3. History of hydrocephalus and/or posterior fossa syndrome;
     4. Younger age at diagnosis.
  2. Parents and teachers will rate patients with a BT as being less socially competent and experiencing more internalizing problems than healthy controls and patients with CF at Time 2, but not at Time 1.
  3. Performance on tests of social cognition will be positively related to executive functions at Time 1 and 2.
  4. Performance on tests of social cognition will be positively related to parent and teacher reports of social competence and environmental biographic factors (parental education and occupation) at Time 1 and 2.
* Objective: To study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a BT in childhood as compared to a reference group of chronically ill children. The focus will be on the neurocognitive basis of such deficits.
* Study design: Comparative Non-randomised Prospective International Multi-Centre Study
* Study population: 49 Children treated for a BT aged 5-13 years, 32 children diagnosed with CF aged 5-13 years and 32 healthy controls aged 5-13 years.

Social Cognition in Children Treated for a Brain Tumour

Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study

Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).

Parent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).

The influence of individual biographical and medical characteristics (age at diagnosis, histology, sex, tumor site, treatment) on change in performance on tests of social cognition from time 1 to time 2.

Radboud University Medical Center

Universitaire Ziekenhuizen KU Leuven

Amsterdam UMC, location VUmc

University Medical Center Groningen

Clinical Neuropsychologist

Behaviors and Mental Disorders

Quality of Life

Executive functions and social cognition will be assessed using cognitive (Stroop task, Modified Card Sorting Task, Digit spans) and behavioral (BRIEF for childrens and BRIEF-A for adults) tests.

Quality of life will be assessed by questionaires (SF-36, QLQC30-BN20 for adults and Peds-Ql for childrens)

measures of executive functioning with tasks

Executive functions

measures of socio-cognitive functioning with tasks

social cognition

measures of quality of life with questionnaires

quality of life

Jeremy Besnard, PhD

Didier Le Gall

Significant advances in primary malignant brain tumors (PBT) treatment have led to dramatically improved survival, both in children and adults. However, survival has not come without a cost and aggressive treatment methods associated with significant long-term adverse effects, often referred to as "late effects" (Panigrahy \& Blüml, 2009). These effects are the medical, physical, cognitive and psychosocial sequelae associated with cancer and its treatments that generally emerge two to five years after treatment ends (e.g., Landier \& Bhatia, 2008).

The most serious challenge survivors of brain tumors face may be cognitive dysfunction. One especially important cognitive domain is executive functioning, which refers to essential factors such as problem-solving, goal-directed behavior and the ability to maintain stable interpersonal relationships (Lezak et al., 2004). Despite the potential impact of executive impairments on behavioral regulation and quality of life, few studies were conducted with survivors of PBT specifically for the assessment of executive functioning. Another fundamental neuro-cognitive domain is social cognition, which refers to the ability to understand the intentions and beliefs of others (Frith \& Singer, 2008). Social cognitive deficits are expected to impair autonomy and relationships, but scarce attention has been devoted to the study of social cognition in survivors of PBT and no study has attempted to compare socio-cognitive data and measures of health-related quality of life. It is noteworthy that executive function and socio-cognitive skills improve throughout childhood and adolescence, and improvements in these skills have frequently been attributed to maturation of the brain, especially the prefrontal cortex (e.g., Tamnes et al., 2010). This suggests a greater impact of the disease and its treatment on these functions in children/adolescents.

First, the investigators will calculate the prevalence of cognitive and socio-cognitive deficits, by comparing the performances of patients (children/adolescents and adults) to normative data available for each tasks and to performances of healthy controls matched on socio-demographic criteria.

Second, the investigators will compare the neuropsychological scores for cognitive and socio-cognitive tasks to health related quality of life (HRQOL) data (composite scores and by domains). Comparisons of neuropsychological and HRQOL scores will be performed between the two populations (children / adolescents and adults).

Third, the investigators will compare the data from the two age groups for the aforementioned variables (cognitive and behavioral executive assessments, cognitive and affective TOM). The proximity of the tasks should provide valid elements of comparison. The investigators will compare the questionnaires in auto-and hetero-evaluation for each HRQOL scales, and also for executive behavioral questionnaires.

Finally, to evaluate the investigators will compare the HRQOL patients/relatives' data to measure the potential impact of the disease on HRQOL of relatives of PBT survivors and the potential link between these data.

Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life

Assessment of Executive and Socio-cognitive Functions in Child and Adult Survivors of Primary Brain Tumor: Impact on Patients' and Relatives' Quality of Life.

Executive functions will be assessed using executive cognitive tasks (Stroop task for inhibition, Modified Card Sorting Task for mental flexibility, Digit spans for working memory) and questionnaires (BRIEF for childrens and BRIEF-A for adults) for executive behavioral measures.

Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. So, these multiple measurements will be aggregated to determine the number of patients with pathological performances for executive tasks (tasks and questionaires).

The first task involves a mental representation or belief about the state of the world (eg, Samson, 2012). The items offered in this kind of task are used to assess the ability to understand that the belief to infer in a type of scenario does not correspond to the reality.

The second task will be the Faux Pas task (Stone et al., 1998). This task is composed of written scenarios and the subject must detect if someone has done or said something he should not have said- the "faux pas". If the subject detects that there was a faux pas, additional questions are asked to detect whether he/she understands the cognitive side and the emotional side of the faux pas.

Standardized norms in French are available for these tasks, which permit determining if the performances are pathological. These multiple measurements will be aggregated to determine the number of patients with pathological performances.

Health-related quality of life (HRQOL) will be assessed in adults with the French validated version of the 36-Item Short Form Survey (SF-36; Ware \& Sherbourne 1992) and a specific questionnaire for assessing quality of life of patients with brain tumors (QLQ-C30-BN20), commonly used in the international literature (eg, Chen et al, 2012;. Pulenzas et al, 2014).

Regarding the HRQOL assessment in children, the choice fell on the Peds-Ql. The PEDS QL measures HRQOL with three major composite assessments -psychosocial, physical, and total HRQOL.

Standardized norms in French are available for questionaires, which permit determining if the performances are pathological. These measurements will be aggregated to determine the number of patients with abnormal performances for these questionaires.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Social Cognition in Children Treated for a Brain Tumour	NCT01599052	Social Behaviou... Brain Neoplasms Cystic Fibrosis		5 Years - 12 Years	University Medical Center Groningen
Executive and Socio-cognitive Functions in Survivors of Primary Brain Tumor: Impact on Patients' Quality of Life	NCT02693405	Primary Brain T... Neurocognition Quality of Life	Executive funct... social cognitio... quality of life	8 Years - 59 Years	University Hospital, Angers

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