Overview

This trial is active, not recruiting.

Conditions social behaviour, brain neoplasms, cystic fibrosis
Sponsor University Medical Center Groningen
Collaborator Radboud University
Start date March 2011
End date March 2017
Trial size 113 participants
Trial identifier NCT01599052, 10.02.20-2010/0042, NL 31489.042.10

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Newly diagnosed brain tumour patients aged between 5 and 13 years
Patients diagnosed with Cystic Fibrosis aged between 5 and 13 years
Healthy children aged between 5 and 13 years

Primary Outcomes

Measure
Social cognitive performance
time frame: baseline and 3 years later

Secondary Outcomes

Measure
Social-emotional competence
time frame: baseline and 3 years later
Influence of Biographical/Medical characteristics
time frame: up to 3 years later

Eligibility Criteria

Male or female participants from 5 years up to 12 years old.

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)

Additional Information

Official title Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study
Principal investigator A Kingma, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Medical Center Groningen.