Social Cognition in Children Treated for a Brain Tumour

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599052
• Other study ID #: 10.02.20-2010/0042
• Secondary ID: NL 31489.042.10
• Status: Completed
• Start date: March 2011
• Est. completion date: March 2017

Study information

• Verified date: August 2021
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Neoplasms
• Cystic Fibrosis
• Social Behaviour

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven	Vlaams-Brabant
Netherlands	Vrije Universiteit Medical Centre	Amsterdam	Noord-Holland
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	University Medical Centre St. Radboud	Nijmegen	Gelderland

Sponsors (4)

Lead Sponsor	Collaborator
University Medical Center Groningen	Radboud University, Universitaire Ziekenhuizen Leuven, VU University Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & Publications (2)

Kok TB, Koerts J, Lemiere J, Post WJ, de Bont ESJM, Gidding C, Happé 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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