Social Cognition in Children Treated for a Brain Tumour
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
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|