Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256425
Status:
UNKNOWN
Last Update Posted:
2008-03-21
First Post:
2005-11-18
Brief Title:
Cognitive Rehabilitation of Glioma Patients
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Cognitive Rehabilitation of Glioma Patients a Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2007-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None