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Cognitive Rehabilitation of Glioma Patients

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: UMC Utrecht
Dutch Cancer Society
Information provided by: UMC Utrecht
ClinicalTrials.gov Identifier: NCT00256425
  Purpose

The purpose of this study is to determine whether cognitive rehabilitation is effective in patients with gliomas (brain tumour), by comparing direct and follow-up neuropsychological functioning and quality of life of the experimental group to the control group.


Condition Intervention Phase
Glioma
Cognition Disorders
Behavioral: Cognitive rehabilitation
Phase III

MedlinePlus related topics:   Cancer    Memory    Rehabilitation   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • neuropsychological measures of attention (test scores) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]

Secondary Outcome Measures:
  • neuropsychological measures of memory and executive functioning (test scores) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]
  • subjective neuropsychological functioning (questionnaires) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]
  • quality of life (questionnaires) [ Time Frame: baseline, immediately after 6 weeks and at 6-month follow-up ]

Enrollment:   140
Study Start Date:   October 2003
Estimated Study Completion Date:   September 2007

Detailed Description:

The majority of patients with (low-grade) glioma exhibit cognitive symptoms and objective deficits, which have a sustained, negative impact on daily functioning and quality of life.

Adult patients with a low-grade glioma, either histologically proven, or suspected (1), as well as adult anaplastic glioma patients with favorable prognostic factors (2), who are clinically stable for at least 6 months, will be recruited from 9 hospitals in the Netherlands. Consenting patients with both subjective cognitive symptoms and objective deficits will be randomized to either the cognitive rehabilitation program (N = 75) or a "waiting-list" control group (N = 75). Upon completion of the study, those patients assigned to the control group will be given the opportunity to undergo the cognitive rehabilitation program.

The cognitive rehabilitation program incorporates both retraining of impaired cognitive functions, and teaching of compensatory strategies. Rehabilitation will be directed towards attention, memory and executive functioning. The intervention will consist of 6 weekly, individual, 2-hour sessions plus two hours of homework.

To evaluate the efficacy of the rehabilitation program, objective neuropsychological functioning, self-reported cognitive symptoms and health-related quality of life will be assessed before rehabilitation, directly following rehabilitation, and at 6-month follow-up.

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and MR imaging feature, and
  • adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (KPS > 70);
  • who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MRI imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids);
  • who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher;
  • and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher).

Exclusion Criteria:

  • lack of basic proficiency in Dutch;
  • IQ below 85;
  • severe reading problems;
  • an additional (history of) neurological or psychiatric disorder;
  • participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256425

Locations
Netherlands
Medical Center Haaglanden    
      Den Haag, Netherlands, 2501 CK
Netherlands Cancer Institute    
      Amsterdam, Netherlands, 1066 CX
Erasmus Medical Center    
      Rotterdam, Netherlands, 3008 AE
Sint Elisabeth Hospital    
      Tilburg, Netherlands, 5000 LC
AZ Maastricht    
      Maastricht, Netherlands, 6202 AZ
UMC St Radboud    
      Nijmegen, Netherlands, 6500 HB
UMC Groningen    
      Groningen, Netherlands, 9700 RB
University Medical Center Utrecht    
      Utrecht, Netherlands, 3584 CX
VU Medical Center    
      Amsterdam, Netherlands, 1007 MB

Sponsors and Collaborators
UMC Utrecht
Dutch Cancer Society

Investigators
Principal Investigator:     Martin JB Taphoorn, MD, PhD     Medical Center Haaglanden    
Principal Investigator:     Neil K Aaronson, PhD     Netherlands Cancer Institute    
Principal Investigator:     Margriet M Sitskoorn, PhD     UMC Utrecht    
  More Information


Dutch Cancer Society Website  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   UU 2003-2783
First Received:   November 18, 2005
Last Updated:   March 20, 2008
ClinicalTrials.gov Identifier:   NCT00256425
Health Authority:   Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
glioma  
brain tumor  
cognit  
neuropsycholog  
attention  
memory
executive function
rehabilitation
remediation
training

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Dementia
Cognition Disorders
Neoplasms, Glandular and Epithelial
Delirium

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on September 19, 2008




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