Social Cognition in Children Treated for a Brain Tumour

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University Medical Centre Groningen
Sponsor:
Collaborators:
Radboud University
Universitaire Ziekenhuizen Leuven
VU University Medical Center
Information provided by (Responsible Party):
Dr. A. Kingma, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01599052
First received: May 11, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose
  • 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.

Condition
Social Behaviour
Brain Neoplasms
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Social Cognition in Children Treated for a Brain Tumour: A Prospective Longitudinal Multi-Centre Study

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Social cognitive performance [ Time Frame: baseline and 3 years later ] [ Designated as safety issue: No ]
    Change in performance on tests of social cognition from time 1 (diagnosis) to time 2 (3 years later).


Secondary Outcome Measures:
  • Social-emotional competence [ Time Frame: baseline and 3 years later ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 113
Study Start Date: March 2011
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Brain tumour (BT) patients will be recruited at paediatric oncology centres in Groningen (UMCG), Nijmegen (UMC St.Radboud) 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).

Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599052

Contacts
Contact: T.B Kok, MSc +31(0)503614144 t.b.kok@umcg.nl
Contact: A Kingma, PhD +31(0)503614144 a.kingma@umcg.nl

Locations
Belgium
University Hospital Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: J. Lemiere, PhD    +32(0)16342235    jurgen.lemiere@uzleuven.be   
Sub-Investigator: J. Lemiere, PhD         
Principal Investigator: S. Van Gool, Professor MD PhD         
Netherlands
University Medical Centre St. Radboud Recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: C.E.M. Gidding, MD PhD    +31(0)3613878    c.gidding@cukz.umcn.nl   
Contact: T.B. Kok, MSc    +31(0)3614144    t.b.kok@umcg.nl   
Sub-Investigator: C.E.M. Gidding, MD PhD         
Sub-Investigator: P.J.F.M. Merkus, MD PhD         
Sub-Investigator: J. Schieving, MD PhD         
Vrije Universiteit Medical Centre Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: K.J. Oostrom, PhD    +31 (0) 204440861    kj.oostrom@vumc.nl   
Contact: T.B. Kok    + 31 (0) 503614144    t.b.kok@umcg.nl   
Sub-Investigator: K.J. Oostrom, PhD         
University Medical Centre Groningen Recruiting
Groningen, Netherlands, 9700RB
Contact: T.B. Kok, MSc    +31(0)3614144    t.b.kok@umcg.nl   
Contact: A Kingma, PhD    +31(0)3614144    a.kingma@umcg.nl   
Sub-Investigator: T.B. Kok, MSc         
Sub-Investigator: E.J.L.E. Vrijlandt, MD PhD         
Principal Investigator: A. Kingma, PhD         
Sponsors and Collaborators
University Medical Centre Groningen
Radboud University
Universitaire Ziekenhuizen Leuven
VU University Medical Center
Investigators
Principal Investigator: A Kingma, PhD Unviersity Medical Centre
  More Information

No publications provided

Responsible Party: Dr. A. Kingma, Clinical Neuropsychologist, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01599052     History of Changes
Other Study ID Numbers: 10.02.20-2010/0042, NL 31489.042.10
Study First Received: May 11, 2012
Last Updated: November 29, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Belgium: Ethics Committee

Keywords provided by University Medical Centre Groningen:
Social Cognition
Theory of Mind
Emotion Recognition
Social competence
Brain Tumour

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Cystic Fibrosis
Fibrosis
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014