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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
VU Medical Center
Amsterdam, Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
AZ Maastricht
Maastricht, Netherlands
neuropsychological measures of attention (test scores)
Time frame: baseline, immediately after 6 weeks and at 6-month follow-up
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
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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