Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2003-10-31
2007-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Cognitive rehabilitation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
UMC Utrecht
OTHER
Principal Investigators
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Martin JB Taphoorn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical Center Haaglanden
Neil K Aaronson, PhD
Role: PRINCIPAL_INVESTIGATOR
The Netherlands Cancer Institute
Margriet M Sitskoorn, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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VU Medical Center
Amsterdam, , Netherlands
Netherlands Cancer Institute
Amsterdam, , Netherlands
UMC Groningen
Groningen, , Netherlands
AZ Maastricht
Maastricht, , Netherlands
UMC St Radboud
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Medical Center Haaglanden
The Hague, , Netherlands
Sint Elisabeth Hospital
Tilburg, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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References
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Klein M, Heimans JJ, Aaronson NK, van der Ploeg HM, Grit J, Muller M, Postma TJ, Mooij JJ, Boerman RH, Beute GN, Ossenkoppele GJ, van Imhoff GW, Dekker AW, Jolles J, Slotman BJ, Struikmans H, Taphoorn MJ. Effect of radiotherapy and other treatment-related factors on mid-term to long-term cognitive sequelae in low-grade gliomas: a comparative study. Lancet. 2002 Nov 2;360(9343):1361-8. doi: 10.1016/s0140-6736(02)11398-5.
Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004 Mar;3(3):159-68. doi: 10.1016/S1474-4422(04)00680-5.
Other Identifiers
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UU 2003-2783
Identifier Type: -
Identifier Source: org_study_id