Social Cognition in Children Treated for a Brain Tumour

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT01599052

Collaborator

Radboud University Medical Center (Other), Universitaire Ziekenhuizen Leuven (Other), Amsterdam UMC, location VUmc (Other)

152

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Social Behaviour Brain Neoplasms Cystic Fibrosis

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:

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:
History of cranial radiation therapy;
Site of lesion in diencephalon;
History of hydrocephalus and/or posterior fossa syndrome;
Younger age at diagnosis.
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.
Performance on tests of social cognition will be positively related to executive functions at Time 1 and 2.
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.

Study Design

Study Type:

Observational

Actual Enrollment :

152 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Brain Tumour Patients Newly diagnosed brain tumour patients aged between 5 and 13 years
Cystic Fibrosis patients Patients diagnosed with Cystic Fibrosis aged between 5 and 13 years
Healthy control group Healthy children aged between 5 and 13 years

Outcome Measures

Primary Outcome Measures

Social cognitive performance [baseline and 3 years later]
Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).

Secondary Outcome Measures

Social-emotional competence [baseline and 3 years later]
Parent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).
Influence of Biographical/Medical characteristics [up to 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Leuven	Leuven	Vlaams-Brabant	Belgium	3000
2	University Medical Centre St. Radboud	Nijmegen	Gelderland	Netherlands	6500HB
3	Vrije Universiteit Medical Centre	Amsterdam	Noord-Holland	Netherlands	1081 HV
4	University Medical Centre Groningen	Groningen		Netherlands	9700RB