Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
18 Years
70 Years
Both
Glioma, Cognition Disorders
Trial Information
Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
neuropsychological measures of attention (test scores)
Outcome Time Frame:
baseline, immediately after 6 weeks and at 6-month follow-up
Principal Investigator
Martin JB Taphoorn, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Medical Center Haaglanden
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
UU 2003-2783
NCT ID:
NCT00256425
Start Date:
October 2003
Completion Date:
September 2007
Related Keywords:
- Glioma
- Cognition Disorders
- glioma
- brain tumor
- cognit
- neuropsycholog
- attention
- memory
- executive function
- rehabilitation
- remediation
- training
- Cognition Disorders
- Glioma
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