Clinical trial NCT01599052: Social Cognition in Children Treated for a Brain Tumour
Official title: Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Behaviour
Brain Neoplasms
Cystic Fibrosis
Keywords: Social Cognition
Theory of Mind
Emotion Recognition
Social competence
Brain Tumour
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: Universitaire Ziekenhuizen KU Leuven
name: Amsterdam UMC, location VUmc
First posted: 2012-05-15
Enrollment: 152
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain tumour (BT) patients will be recruited at paediatric oncology centres in Groningen (UMCG), Nijmegen (UMC St.Radboud), Amsterdam (VUmc) and Leuven (UZL).

Cystic Fibrosis (CF) patients will be recruited at the department of paediatric lung diseases in Groningen (UMCG) and Nijmegen (UMC St. Radboud).

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

* Aged 5-13 years at first assessment (All groups)
* Newly diagnosed brain tumour patients that have not yet received adjuvant therapy (BT patients only)
* Stable medical condition (BT and CF patients only)

Exclusion Criteria:

* Diagnosed with a disorder of the autistic spectrum (Autism, Asperger's Syndrome or Pervasive Developmental Disorder not otherwise specified - All groups) that does not seem to be related to the tumour (BT patients only).
* History of other brain disease or neurological condition interfering with normal development (All groups).
* No native Dutch speaker (All groups)
* Severe sensory handicaps and/or behavioural problems interfering with reliable neuropsychological assessment (All groups)
* IQ below 70 (All groups)
* Poor prognosis and life expectancy less than 1 year (BT patients only)

Primary outcomes:
measure: Social cognitive performance
timeFrame: baseline and 3 years later
Secondary outcomes:
measure: Social-emotional competence
timeFrame: baseline and 3 years later
measure: Influence of Biographical/Medical characteristics
timeFrame: up to 3 years later
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-Brabant
city: Nijmegen
country: Netherlands
facility: University Medical Centre St. Radboud
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Medical Centre
state: Noord-Holland
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
affiliation: Unviersity Medical Centre
name: A Kingma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kok TB, Post WJ, Tucha O, de Bont ES, Kamps WA, Kingma A. Social competence in children with brain disorders: a meta-analytic review. Neuropsychol Rev. 2014 Jun;24(2):219-35. doi: 10.1007/s11065-014-9256-7. Epub 2014 Mar 20.
citation: Kok TB, Koerts J, Lemiere J, Post WJ, de Bont ESJM, Gidding C, Happe F, Jacobs S, Oostrom K, Schieving J, Tucha O, Kingma A. Social competence in newly diagnosed pediatric brain tumor patients. Pediatr Hematol Oncol. 2020 Feb;37(1):41-57. doi: 10.1080/08880018.2019.1682089. Epub 2019 Nov 4.