- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2011-03
2017-03
2017-03
152
NCT01599052
University Medical Center Groningen
University Medical Center Groningen
OBSERVATIONAL
Social Cognition in Children Treated for a Brain Tumour
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.
* 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2012-05-11 | N/A | 2021-08-31 |
2012-05-14 | N/A | 2021-09-01 |
2012-05-15 | N/A | 2021-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
5 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
