Social Cognition in Children Treated for a Brain Tumour

NCT01599052 | Completed

• 2 other identifiers: 10.02.20-2010/0042NL 31489.042.10
• Study Type: observational
• Target: 152
• Locations: 2 countries
• Sites: 4

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.

Conditions

Social Behaviour; Brain Neoplasms; Cystic Fibrosis

Keywords

Social Cognition; Theory of Mind; Emotion Recognition; Social competence; Brain Tumour

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Social-emotional competence

  baseline and 3 years later

• Influence of Biographical/Medical characteristics

  up to 3 years later

Study Arms (3)

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

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Radboud University Medical Center: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (4)

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

University Medical Centre St. Radboud

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Vrije Universiteit Medical Centre

Amsterdam, North Holland, 1081 HV, Netherlands

Location

University Medical Centre Groningen

Groningen, 9700RB, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 24648014 BACKGROUND

• 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.

  PMID: 31682775 BACKGROUND

MeSH Terms

Conditions

Social Behavior; Brain Neoplasms; Cystic Fibrosis; Social Skills

Condition Hierarchy (Ancestors)

Behavior; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• A Kingma, PhD

  Unviersity Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Neuropsychologist

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 15, 2012
• Study Start: March 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

NL (3); BE (1)