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van CCT (UK)

van CCT (UK)

Cognitive deficits in brain tumor patients after neurosurgery: incidence, severity and prediction of outcome

- candidate number22312
- NTR NumberNTR5194
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jun-2015
- Secondary IDs842003007; NL41351.008.12 ZonMw Projectnumber; protocol ID MEC
- Public TitleCognitive deficits in brain tumor patients after neurosurgery: incidence, severity and prediction of outcome
- Scientific TitleCognitive deficits in brain tumor patients after neurosurgery: incidence, severity and prediction of outcome
- hypothesisObjectives:

1) To describe the incidence and severity of cognitive impairments in patients with glioma and meningiomas before, and 3 and 12 months after surgical treatment.

2) To develop models based on presurgical sociodemographic, clinical, imaging, and (neuro)psychological variables that predict cognitive functioning one year after surgery.

3) To increase knowledge on fatigue, work status, work limitations, and community integration, and their relationship with cognition (over time) in order to improve care for patients with primary brain tumors.
- Healt Condition(s) or Problem(s) studiedBrain tumor, Cognitive functioning
- Inclusion criteriaAdult patients with supratentorial gliomas and meningiomas undergoing resective surgery in the St. Elisabeth Hospital, Tilburg. Eligible subjects for the control group (recruited from the general population and matched for age, gender and educational level) should be in good health, with no current or past psychiatric, neurologic, or cognitive disorder, and medication-use that interferes with cognitive function.
- Exclusion criteriaPatients and Dutch control subjects will be excluded if 1) they lack of basic proficiency in Dutch, 2) they have an IQ below 85 or low cognitive skills, 3) their Karnovsky Performance Scale is under 60, 4) they are completely unfamiliair with the use of computers, 5) they have an additional (history of) significant neurological or psychiatric disorder, 6) there is a surgery related complication (morbidity or mortality).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 15-nov-2010
- planned closingdate1-nov-2019
- Target number of participants200
- Interventionsn/a
- Primary outcomeChanges in objective cognitive functioning from pre-surgery to post-surgery, as measured with a computerized neuropsychological test battery, CNS Vital Signs.
- Secondary outcomeDepression, anxiety, subjective cognitive complaints, fatigue, community integration and professional functioning, as measured with the Hospital Anxiety and Depression Scale (HADS), the Cognitive Failures Questionnaire (CFQ), Multidimensional Fatigue Inventory (MFI), Community Integration Questionnaire (CIQ), Work Ability Index (WAI) and Work Limitations Questionnaire (WLQ) respectively.
- TimepointsPatients will complete preoperative (i.e., at the day of hospitalization one day before surgery) neuropsychological tests and questionnaires and will be followed up at 3 and 12 months after surgery. Healthy controls will be tested at the same time points.
- Trial web site
- statusopen: patient inclusion
- 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
- PublicationsCognitive improvement in meningioma patients after surgery: Clinical relevance of computerized testing. Meskal, I., Gehring, K., van der Linden, S.D., Rutten, G-J.M. & Sitskoorn, M.M. 2015 In: Journal of Neuro-Oncology, 121(3), 617-625
- Brief summaryDeficits in cognitive functions are common in patients with primary brain tumors. These cognitive deficits can be very subtle, and easily go undetected on routine clinical examination. However, they are often very disruptive for a personís quality of life, preventing return to a normal social and professional life.
Preservation of cognitive functioning is an important outcome measure in glioma surgery, and essential for quality of life. At present, unfortunately, it is largely unknown how surgery affects cognition. A better understanding of the variables that predict the impact of surgery on cognition is of significant importance not only to patients and their families, but also to neurosurgeons. It provides neurosurgeons with evidence-based information about possible individual risk of surgery which will steer clinical decision making and enables to inform patients better about the consequences of surgery on long-term cognitive functioning.
- Main changes (audit trail)
- RECORD5-jun-2015 - 20-jul-2015

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