Overview

This trial is active, not recruiting.

Conditions glioma, cognition disorders
Treatment cognitive rehabilitation
Phase phase 3
Sponsor UMC Utrecht
Collaborator Dutch Cancer Society
Start date October 2003
End date September 2007
Trial size 140 participants
Trial identifier NCT00256425, UU 2003-2783

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
neuropsychological measures of attention (test scores)
time frame: baseline, immediately after 6 weeks and at 6-month follow-up

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - adult patients with a histologically proven low-grade glioma or presumed (i.e., suspected) low-grade glioma based on both clinical and MR imaging feature, and - adult patients with an anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligo-astrocytoma) under age 50 and with good performance status (KPS > 70); - who are clinically stable for a minimum of 6 months prior to study entry (as determined by recent CT or MRI imaging) and no anti-tumor treatment during that period of time (i.e., surgery, radiotherapy, chemotherapy, corticosteroids); - who report at least one symptom of impaired cognitive functioning based on a standardized self-report questionnaire, administered by researcher; - and who meet criteria for neuropsychological impairment based on objective test results (assessed by researcher). Exclusion Criteria: - lack of basic proficiency in Dutch; - IQ below 85; - severe reading problems; - an additional (history of) neurological or psychiatric disorder; - participating in a concurrent study in which neuropsychological testing and/or health-related quality of life assessments are involved

Additional Information

Official title Cognitive Rehabilitation of Glioma Patients: a Prospective, Randomized Study
Principal investigator Martin JB Taphoorn, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by UMC Utrecht.