Social Cognition in Children Treated for a Brain Tumour
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|ClinicalTrials.gov Identifier: NCT01599052|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2012
Last Update Posted : October 25, 2017
|Condition or disease|
|Social Behaviour Brain Neoplasms Cystic Fibrosis|
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:
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:
- History of cranial radiation therapy;
- Site of lesion in diencephalon;
- History of hydrocephalus and/or posterior fossa syndrome;
- Younger age at diagnosis.
- 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.
- Performance on tests of social cognition will be positively related to executive functions at Time 1 and 2.
- 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|
|Estimated Enrollment :||113 participants|
|Official Title:||Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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
- Social cognitive performance [ Time Frame: baseline and 3 years later ]Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).
- Social-emotional competence [ Time Frame: baseline and 3 years later ]Parent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).
- Influence of Biographical/Medical characteristics [ Time Frame: up to 3 years later ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599052
|University Hospital Leuven|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|University Medical Centre St. Radboud|
|Nijmegen, Gelderland, Netherlands, 6500HB|
|Vrije Universiteit Medical Centre|
|Amsterdam, Noord-Holland, Netherlands, 1081 HV|
|University Medical Centre Groningen|
|Groningen, Netherlands, 9700RB|
|Principal Investigator:||A Kingma, PhD||Unviersity Medical Centre|