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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive rehabilitation | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| neuropsychological measures of attention (test scores) | baseline, immediately after 6 weeks and at 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| neuropsychological measures of memory and executive functioning (test scores) | baseline, immediately after 6 weeks and at 6-month follow-up | |
| subjective neuropsychological functioning (questionnaires) | baseline, immediately after 6 weeks and at 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Center | Amsterdam | 1007 MB | Netherlands | |||
| Netherlands Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12423981 | Background | 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. | |
| 14980531 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 19, 2011 | |
| Reset | Aug 11, 2011 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 19, 2011 | Aug 11, 2011 |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D003072 | Cognition Disorders |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| quality of life (questionnaires) | baseline, immediately after 6 weeks and at 6-month follow-up |
| Amsterdam |
| 1066 CX |
| Netherlands |
| UMC Groningen | Groningen | 9700 RB | Netherlands |
| AZ Maastricht | Maastricht | 6202 AZ | Netherlands |
| UMC St Radboud | Nijmegen | 6500 HB | Netherlands |
| Erasmus Medical Center | Rotterdam | 3008 AE | Netherlands |
| Medical Center Haaglanden | The Hague | 2501 CK | Netherlands |
| Sint Elisabeth Hospital | Tilburg | 5000 LC | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| Background |
| 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. |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |