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Brief Title: Cognitive Rehabilitation of Glioma Patients
Official Title: Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
Study ID: NCT00256425
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
VU Medical Center, Amsterdam, , Netherlands
Netherlands Cancer Institute, Amsterdam, , Netherlands
Medical Center Haaglanden, Den Haag, , Netherlands
UMC Groningen, Groningen, , Netherlands
AZ Maastricht, Maastricht, , Netherlands
UMC St Radboud, Nijmegen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Sint Elisabeth Hospital, Tilburg, , Netherlands
University Medical Center Utrecht, Utrecht, , Netherlands
Name: Martin JB Taphoorn, MD, PhD
Affiliation: Medical Center Haaglanden
Role: PRINCIPAL_INVESTIGATOR
Name: Neil K Aaronson, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Margriet M Sitskoorn, PhD
Affiliation: UMC Utrecht
Role: PRINCIPAL_INVESTIGATOR