Social BehaviourNCT01599052
Social Cognition in Children Treated for a Brain Tumour
An observational study of Social Behaviour and Brain Neoplasms, run by University Medical Center Groningen at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Behaviour, Brain Neoplasms, Cystic Fibrosis
- How many people
- 152 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2011to Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Brain tumour (BT) patients will be recruited at paediatric oncology centres in Groningen (UMCG), Nijmegen (UMC St.Radboud), Amsterdam (VUmc) and Leuven (UZL). Cystic Fibrosis (CF) patients will be recruited at the department of paediatric lung diseases in Groningen (UMCG) and Nijmegen (UMC St. Radboud).
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands3 sites
Vrije Universiteit Medical Centre
Amsterdam, North Holland, 1081 HV
University Medical Centre Groningen
Groningen, 9700RB
University Medical Centre St. Radboud
Nijmegen, Gelderland, 6500HB
About this study
Official title: Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study
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.
Read the detailed 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:
- 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.
- Conditions
- Social Behaviour, Brain Neoplasms, Cystic Fibrosis
- Keywords
- Social Cognition, Theory of Mind, Emotion Recognition, Social competence, Brain Tumour
- Medical subject headings
- Social Behavior, Brain Neoplasms, Cystic Fibrosis, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social cognitive performance
Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).
Measured: baseline and 3 years later
Secondary outcomes (2)
Social-emotional competence
Parent and Teacher reports of social and emotional functioning from time 1 (diagnosis) to time 2 (3 years later).
Measured: 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.
Measured: up to 3 years later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social BehaviourStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven, Amsterdam UMC, location VUmc
- Responsible party
- Principal investigator, Dr. A. Kingma, University Medical Center Groningen
- Investigators
- A Kingma, PhD, Principal investigator, Unviersity Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599052
- Sponsor's protocol ID
- 10.02.20-2010/0042
- Other IDs
- NL 31489.042.10
- Status last verified
- Aug 2021
- First submitted
- 11 May 2012
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kok TB, Post WJ, Tucha O, de Bont ES, Kamps WA, Kingma A. Social competence in children with brain disorders: a meta-analytic review. Neuropsychol Rev. 2014 Jun;24(2):219-35. doi: 10.1007/s11065-014-9256-7. Epub 2014 Mar 20.
PubMed 24648014Kok TB, Koerts J, Lemiere J, Post WJ, de Bont ESJM, Gidding C, Happe F, Jacobs S, Oostrom K, Schieving J, Tucha O, Kingma A. Social competence in newly diagnosed pediatric brain tumor patients. Pediatr Hematol Oncol. 2020 Feb;37(1):41-57. doi: 10.1080/08880018.2019.1682089. Epub 2019 Nov 4.
PubMed 31682775
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study
- ClinicalTrials.gov ID
- NCT01599052
- Acronym / sponsor ID
- 10.02.20-2010/0042
- Conditions
- Social Behaviour, Brain Neoplasms, Cystic Fibrosis
- Keywords
- Social Cognition, Theory of Mind, Emotion Recognition, Social competence, Brain Tumour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Universitaire Ziekenhuizen KU Leuven, Amsterdam UMC, location VUmc
- Study start
- Mar 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Brain tumour (BT) patients will be recruited at paediatric oncology centres in Groningen (UMCG), Nijmegen (UMC St.Radboud), Amsterdam (VUmc) and Leuven (UZL). Cystic Fibrosis (CF) patients will be recruited at the department of paediatric lung diseases in Groningen (UMCG) and Nijmegen (UMC St. Radboud).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
Social-emotional competence
Time frame: baseline and 3 years later
Influence of Biographical/Medical characteristics
Time frame: up to 3 years later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 24648014Kok TB, Post WJ, Tucha O, de Bont ES, Kamps WA, Kingma A. Social competence in children with brain disorders: a meta-analytic review. Neuropsychol Rev. 2014 Jun;24(2):219-35. doi: 10.1007/s11065-014-9256-7. Epub 2014 Mar 20.
- Background: PubMed 31682775Kok TB, Koerts J, Lemiere J, Post WJ, de Bont ESJM, Gidding C, Happe F, Jacobs S, Oostrom K, Schieving J, Tucha O, Kingma A. Social competence in newly diagnosed pediatric brain tumor patients. Pediatr Hematol Oncol. 2020 Feb;37(1):41-57. doi: 10.1080/08880018.2019.1682089. Epub 2019 Nov 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Kingma, PhD principal investigator
Unviersity Medical Centre
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Social Behaviour and Brain Neoplasms, run by University Medical Center Groningen at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social cognitive performance (time frame: baseline and 3 years later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599052, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.