Social Cognition in Children Treated for a Brain Tumour

NCT ID: NCT01599052

Last Updated: 2021-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 152 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Social Behaviour; Brain Neoplasms; Cystic Fibrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Brain Tumour Patients

Newly diagnosed brain tumour patients aged between 5 and 13 years

No interventions assigned to this group

Cystic Fibrosis patients

Patients diagnosed with Cystic Fibrosis aged between 5 and 13 years

No interventions assigned to this group

Healthy control group

Healthy children aged between 5 and 13 years

No interventions assigned to this group

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Dr. A. Kingma

Clinical Neuropsychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

A Kingma, PhD

Role: PRINCIPAL_INVESTIGATOR

Unviersity Medical Centre

Locations

University Hospital Leuven

Leuven, Vlaams-Brabant, Belgium

University Medical Centre St. Radboud

Nijmegen, Gelderland, Netherlands

Vrije Universiteit Medical Centre

Amsterdam, North Holland, Netherlands

University Medical Centre Groningen

Groningen, , Netherlands

Countries

Belgium; Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 24648014 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31682775 (View on PubMed)

Other Identifiers

NL 31489.042.10

Identifier Type: REGISTRY

Identifier Source: secondary_id

10.02.20-2010/0042

Identifier Type: -

Identifier Source: org_study_id