Cognitive Rehabilitation of Glioma Patients
Recruitment status was Active, not recruiting
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study |
- 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 ]
| Enrollment: | 140 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | September 2007 |
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 |
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| Netherlands | |
| Netherlands Cancer Institute | |
| Amsterdam, Netherlands, 1066 CX | |
| VU Medical Center | |
| Amsterdam, Netherlands, 1007 MB | |
| Medical Center Haaglanden | |
| Den Haag, Netherlands, 2501 CK | |
| UMC Groningen | |
| Groningen, Netherlands, 9700 RB | |
| AZ Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| UMC St Radboud | |
| Nijmegen, Netherlands, 6500 HB | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| Sint Elisabeth Hospital | |
| Tilburg, Netherlands, 5000 LC | |
| University Medical Center Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Principal Investigator: | Martin JB Taphoorn, MD, PhD | Medical Center Haaglanden |
| Principal Investigator: | Neil K Aaronson, PhD | The Netherlands Cancer Institute |
| Principal Investigator: | Margriet M Sitskoorn, PhD | UMC Utrecht |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00256425 History of Changes |
| Other Study ID Numbers: | UU 2003-2783 |
| Study First Received: | November 18, 2005 |
| Last Updated: | March 20, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Cognition Disorders Glioma Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013