Status:
UNKNOWN
Cognitive Rehabilitation of Glioma Patients
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Dutch Cancer Society
Conditions:
Glioma
Cognition Disorders
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 qu...
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00256425
Start Date
October 1 2003
End Date
September 1 2007
Last Update
March 21 2008
Active Locations (9)
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1
VU Medical Center
Amsterdam, Netherlands, 1007 MB
2
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX
3
UMC Groningen
Groningen, Netherlands, 9700 RB
4
AZ Maastricht
Maastricht, Netherlands, 6202 AZ