Social Cognition in Children Treated for a Brain Tumour

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms; Cystic Fibrosis; Social Behaviour

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.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • University Hospital Leuven
• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Centre Groningen
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500HB
      • University Medical Centre St. Radboud
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081 HV
      • Vrije Universiteit Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social cognitive performance	Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).	baseline and 3 years later

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Radboud University Medical Center; Universitaire Ziekenhuizen KU Leuven; Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: A Kingma, PhD, Unviersity Medical Centre

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 11, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Social Cognition; Social competence; Theory of Mind; Emotion Recognition; Brain Tumour
• Additional Relevant MeSH Terms: Digestive System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Central Nervous System Neoplasms; Nervous System Neoplasms; Pancreatic Diseases; Brain Neoplasms; Cystic Fibrosis
• Other Study ID Numbers: 10.02.20-2010/0042; NL 31489.042.10 (Registry Identifier: CCMO)