Primary Objective: 1) To study impairment and developmental delay in social cognition (and related cognitive functions) caused by brain damage in patients treated for a brain tumour in childhood as compared to a reference group of chronically ill…
ID
Source
Brief title
Condition
- Other condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Health condition
neuropsychologische stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in performance on tests of social cognition from time 1 to time 2.
Secondary outcome
1) Change in reports of social and emotional functioning of patients
themselves, parents and teachers from time 1 to time 2.
2) Influence of Individual medical characteristics on the change in performance
on tests of social cognition from time 1 to time 2.
3) Influence of Socio-economical status (parental education and occupation) on
the change in performance on tests of social cognition from time 1 to time 2
4) Influence of Intelligence level and Executive Functions on the change in
performance on tests of social cognition from time 1 to time 2.
Background summary
It is known that children treated for a brain tumour often develop deficits in
their social and emotional functioning (page 8 and 9 research protocol). We
would like to examine how these problems arise and propose underlying
neuropsychological deficits in social cognition to be the cause.
From the reviewed literature and clinical practice, the following hypotheses on
short and long-term outcome on measures of social cognition have been
formulated. *Time 1* refers to neuropsychological testing at the time of
diagnosis and *time 2* refers to assessment about 3 years post diagnosis.
Patients will be compared to both healthy and chronically ill children (whose
central nervous system is not affected by their illness).
1) Children treated for a brain tumour will perform worse than a healthy
control group and a control group of chronically ill children on measures of
social cognition at time 2, but not at time 1. The deterioration in performance
will be influenced by the following factors in such a way that we expect
patients with one or more of these factors to have worse performance than those
who do not show these characteristics:
a) History of CRT;
b) Site of lesion in diencephalon;
c) History of hydrocephalus and/or PFS.
2) Parents and/or teachers will rate patients as being less socially competent
and experiencing more internalizing problems than healthy controls and
chronically ill children at time 2, but not at time 1.
3) Performance on tests of ToM will be positively related to executive
functions at time 1 and 2.
4) Performance on tests of ToM will be positively related to parent and teacher
reports of social competence and environmental factors (parental education and
occupation) at time 1 and 2.
Study objective
Primary Objective:
1) To study impairment and developmental delay in social cognition (and related
cognitive functions) caused by brain damage in patients treated for a brain
tumour in childhood as compared to a reference group of chronically ill
children. The focus will be on the neurocognitive basis of such deficits.
Secondary Objectives:
1) To compare performance of BT patients on tests of social cognition to
performance of healthy children.
2) Identify disease and treatment factors that can cause impairments and delays
in social cognition.
3) Make recommendations for the future development of treatments for patients
who have been diagnosed with problems in the social domain.
Study design
The study that will be conducted has a comparative prospective design. Newly
diagnosed children with a BT will be assessed at two separate occasions. The
first time will be directly after diagnosis and preferably before surgery.
Experience from earlier research and clinical work in our department shows this
is feasible. If this is not possible than assessment should take place before
the start of any adjuvant therapy. In case of high intracranial pressure,
assessment is planned between treatment of hydrocephalus and tumor resection.
The second assessment will be conducted three years post diagnosis. Both times
parents and teachers will be asked to complete questionnaires. The assessments
will be carried out at the department of Paediatric Oncology of the Beatrix
Children*s Hospital, UMC Groningen, UMCSt. Radboud Nijmegen, VU medical center
Amsterdam and UZ Leuven, Belgium. Simultaneously, chronically ill children
diagnosed with CF (recruited from the department of Paediatric Lung diseases of
the Beatrix Children*s Hospital, UMC Groningen and UMC St. Radboud) and healthy
children will be assessed with the same protocol.
Study burden and risks
The reason for conducting this study with minors is because we want to examine
development after treatment for a BT. More specific we wish to study if and how
impairments in social cognition arise over time. Children will receive two
neuropsychological evaluations. At the first assessment children will always be
admitted to the hospital with no extra visit; the second assessment will be
combined with other hospital visits as often as possible. Participating
children do not undergo any medical procedures and participation will not
interfere with their standard medical treatment and neuropsychological
evaluation and support. Therefore, the investigators see no risks for
participating in this study. The main disadvantage of the study is the time
investment. However, as most patients that will participate in this study would
have been seen by a neuropsychologist anyway considering current practice in
patient care, there is an overlap between tests used in the research study and
in the current standard evaluation. Only two tests examining social cognition
are additional. Furthermore, mental capacity and age of the patient are taken
well into consideration during assessments. Moreover, it is important to
mention that children generally enjoy neuropsychological assessments; even
shortly after diagnosis, children consider assessments a welcome distraction
from medical procedures. The advantage of participating is that, in addition to
the (standard) information parent receive about their child*s
neuropsychological functioning, specific information about the social and
emotional development of their child can be given. Based on the findings
parents will be advised about the optimal support and upbringing of their
child. The study is considered to be group-related because it could not be
conducted without the participation of children diagnosed with a BT.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
Brain tumour patients:
1) Aged 5-12 years at first assessment
2) Newly diagnosed brain tumour patients that have not yet received adjuvant therapy
3) Stable medical condition;Healthy controls:
1) Aged 5-12 years at first assessment ;CF patients:
1) Aged 5-12 years at first assessment
2) Stable medical condition
Exclusion criteria
Brain tumour patients:
1) Diagnosed with a disorder of the autistic spectrum, not related to the tumour (Autism, Asperger*s Syndrome or Pervasive Developmental Disorder not otherwise specified).
2) History of other brain disease or neurological condition interfering with normal development.
3) No native Dutch speaker
4) Severe sensory handicaps and/or behavioural problems interfering with reliable neuropsychological assessment
5) IQ below 70
6) Poor prognosis and life expectancy less than 1 year.;Healthy controls:
1) Diagnosed with a disorder of the autistic spectrum (Autism, Asperger*s Syndrome or Pervasive Developmental Disorder not otherwise specified).
2) History of other brain disease or neurological condition interfering with normal development.
3) No native Dutch speaker
4) Severe sensory handicaps and/or behavioural problems interfering with reliable neuropsychological assessment.
5) IQ below 70;CF patients:
1) Diagnosed with a disorder of the autistic spectrum (Autism, Asperger*s Syndrome or Pervasive Developmental Disorder not otherwise specified).
2) History of other brain disease or neurological condition interfering with normal development.
3) No native Dutch speaker
4) Severe sensory handicaps and/or behavioural problems interfering with reliable neuropsychological assessment.
5) IQ below 70
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT01599052 |
CCMO | NL31489.042.10 |