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Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
VU Medical Center
Amsterdam, Netherlands
Netherlands Cancer Institute
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
AZ Maastricht
Maastricht, Netherlands
UMC St Radboud
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Medical Center Haaglanden
The Hague, Netherlands
Sint Elisabeth Hospital
Tilburg, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Start Date
October 1, 2003
Completion Date
September 1, 2007
Last Updated
March 21, 2008
140
ACTUAL participants
Cognitive rehabilitation
BEHAVIORAL
Lead Sponsor
UMC Utrecht
Collaborators
NCT05099003
NCT06860594
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05839379