Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
NCT ID: NCT03373487
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
115 participants
INTERVENTIONAL
2015-07-01
2019-06-30
Brief Summary
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Detailed Description
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HYPOTHESIS: Cognitive telerehabilitation after brain tumor surgery has both immediate and longer-term beneficiary effects on cognitive functioning and patient-reported outcomes.
STUDY DESIGN: In the first 6 months of the project a feasibility study will be conducted to ensure that adherence, patient experience, and potential attrition are acceptable.
Subsequently, a prospective randomized (waiting-list) controlled trial (RCT) will be performed. Information from the feasibility study will be used to modify the RCT when necessary. In the RCT, patients are randomized to early cognitive rehabilitation (3 months after surgery) or to a waiting-list control condition. The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments. Assessment of cognitive performance and self-reported symptoms will be performed prior to surgery (T0), before cognitive rehabilitation (3 months after surgery, T3), immediately after cognitive rehabilitation (6 months after surgery, T6), and at half-year follow up (12 months after surgery, T12).
STUDY POPULATION/SAMPLE SIZE: Patients with presumed low-grade glioma or meningioma, who are scheduled for resective surgery, will be included in the study. Fifteen patients will be invited in feasibility study. Based on the yearly numbers of meningioma and low-grade glioma patients that are operated in the Elisabeth-TweeSteden Hospital Tilburg, it is expected that 60 patients will be randomized in the RCT per year for 2.5 years. With a maximum attrition rate of 33%, a minimum of 100 patients (50 per group) will be evaluated.
INTERVENTION: An evidence-based cognitive rehabilitation program that is provided via a tablet app. The program consists of 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 this home-based program. They are monitored and supervised by a trainer.
OUTCOME MEASURES: Feasibility (accrual, attrition, adherence, patient experience) will be monitored in the feasibility study.
At 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). Questionnaires on self-reported cognitive functioning, psychological symptoms (anxiety and depression), and fatigue will be administered on all assessments; the questionnaires on work status, professional functioning and community integration are administered at baseline and one-year follow-up only.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early-intervention group
Patients follow the evidence-based cognitive rehabilitation program ReMind, which is provided via an iPad. It incorporates psychoeducation, strategy training and retraining. The intervention commenced 3 months after surgery and patients were advised to spend 3 hours per week on the program for 10 weeks.
The cognitive rehabilitation program ReMind
Cognitive rehabilitation, i.e. psychoeducation, strategy training \& retraining
Waiting-list control group
The waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery.
The cognitive rehabilitation program ReMind
Cognitive rehabilitation, i.e. psychoeducation, strategy training \& retraining
Interventions
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The cognitive rehabilitation program ReMind
Cognitive rehabilitation, i.e. psychoeducation, strategy training \& retraining
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient will undergo resective surgery for the brain tumor
Exclusion Criteria
* progressive neurological disease
* diagnose of (acute) psychiatric or neurological disorders in the last 2 years
* chemotherapy in the last 2 years
* Karnovsky Performance Scale under 70
* Surgery-related complication (morbidity or mortality e.g., thrombosis or heart attack)
* Lack of basic proficiency in Dutch
* IQ below 85, or (very) low cognitive skills
* Insufficient reading skills/visual impairment (limiting the ability to follow the cognitive rehabilitation program).
* Clinical referral to cognitive rehabilitation
18 Years
ALL
No
Sponsors
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Tilburg University
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Erasmus Medical Center
OTHER
Medical Center Haaglanden
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Responsible Party
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Locations
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Erasmus Medical Center
Rotterdam, , Netherlands
Medical Center Haaglanden
The Hague, , Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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842003009
Identifier Type: -
Identifier Source: org_study_id
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