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van CCT (UK)

van CCT (UK)

Cognitive rehabilitation in brain tumor patients after neurosurgery

- candidate number22868
- NTR NumberNTR5392
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-sep-2015
- Secondary IDsMETC Brabant protocol P.1449 ZonMw projectnumber 842003009
- Public TitleCognitive rehabilitation in brain tumor patients after neurosurgery
- Scientific TitleCognitive rehabilitation in brain tumor patients after neurosurgery
- hypothesisOBJECTIVE: To evaluate the immediate and longer-term effects of early cognitive rehabilitation on cognitive performance and self-reported symptoms/functioning in patients with low-grade gliomas and meningiomas, in a prospective randomized trial.
HYPOTHESIS: Cognitive rehabilitation after brain tumor surgery has both immediate and longer-term beneficiary effects on cognitive functioning and patient-reported outcomes.
- Healt Condition(s) or Problem(s) studiedCognitive functions, Brain tumor
- Inclusion criteriaThe adult patient has a brain tumor that is radiologically suspect for either a meningioma or low grade glioma*; The patient will undergo craniotomy for the brain tumor; The patient is in clinical reasonable or good condition (Karnovsky performance Scale >=70).
- Exclusion criteriaHistory of intracranial neurosurgery; history of severe psychiatric or neurological disorders; lack of basic proficiency in Dutch; IQ below 85, or (very) low cognitive skills; Karnovsky Performance Scale under 70; complete unfamiliarity with the use of computers; surgery-related complication; insufficient reading skills.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate30-jun-2019
- Target number of participants152
- InterventionsEvidence-based cognitive rehabilitation program that is provided via a tablet app. The program aims both retraining, and teaching and practicing of compensational strategies of attention, memory and executive functioning. Patients spend 3 hours per week during 2.5 month in a home-based program. They are monitored and supervised by a trainer. The waitinglist control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments.
- Primary outcomeFeasibility (adherence, patient experience, attrition) and cognitive functioning (group and individual neuropsychological performance, as assessed with the computerized battery of neuropsychological tests and the two additional neuropsychological tests) and magnitude of change over time.
- Secondary outcomeSelfreported cognitive functioning, psychological symptoms (anxiety and depression), fatigue, professional functioning, community integration, selfreported and informantreported executive functioning.
- TimepointsAt several time points during the RCT, patients will be tested with the computerized test battery (for cognition; CNS VS), two additional cognitive tests and several self-report questionnaires. Testing is done prior to surgery, prior to cognitive rehabilitation (3 months), immediately after cognitive rehabilitation (6 months) and at half-year follow up (12 months post-surgery).
- Trial web site
- statusplanned
- Sponsor/Initiator St. Elisabeth Hospital, Tilburg, Tilburg University
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryDeficits in cognitive function are common in patients with primary brain tumors. Remarkably few studies have been directed towards the rehabilitation of the cognitive deficits in brain tumor patients. The purpose of the proposed project is to evaluate the immediate and longterm effects of cognitive rehabilitation in a prospective randomized trial on neuropsychological test performance and selfreported cognitive symptoms, psychological symptoms (anxiety and depression), fatigue, professional functioning and community integration. In the first 6 months of the project a feasibility study will be conducted to ensure that adherence, patient experience, and potential attrition are according to our expectations. Subsequently, a prospective randomized (waitinglist) controlled trial (RCT) will be performed. In the RCT, patients are randomized to early cognitive rehabilitation (3 months after surgery) or to a waitinglist control condition. Outcome assessment of cognitive performance and selfreported symptoms/functioning will be prior to surgery, before cognitive rehabilitation (3 months), immediately after cognitive rehabilitation (6 months), and at halfyear follow up (12 months postsurgery), and at similar intervals for the waitinglist control group.
- Main changes (audit trail)
- RECORD14-sep-2015 - 17-okt-2015

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