Cognitive Rehabilitation of Glioma Patients
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|ClinicalTrials.gov Identifier: NCT00256425|
Recruitment Status : Unknown
Verified July 2007 by UMC Utrecht.
Recruitment status was: Active, not recruiting
First Posted : November 21, 2005
Last Update Posted : March 21, 2008
|Condition or disease||Intervention/treatment||Phase|
|Glioma Cognition Disorders||Behavioral: Cognitive rehabilitation||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study|
|Study Start Date :||October 2003|
|Estimated Study Completion Date :||September 2007|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256425
|VU Medical Center|
|Amsterdam, Netherlands, 1007 MB|
|Netherlands Cancer Institute|
|Amsterdam, Netherlands, 1066 CX|
|Medical Center Haaglanden|
|Den Haag, Netherlands, 2501 CK|
|Groningen, Netherlands, 9700 RB|
|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|