Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
1 other identifier
interventional
115
1 country
3
Brief Summary
Many patients with primary brain tumors experience cognitive deficits and cognitive rehabilitation programs aim to alleviate these deficits.The cognitive rehabilitation program developed by the investigators proved effective in a large randomized controlled trial (RCT). To increase its accessibility, it was converted into the iPad-based cognitive rehabilitation program ReMind, which incorporates psychoeducation, strategy training and retraining. A pilot study and a randomized controlled trial are conducted, to evaluate the feasibility of the use of the program and the efficacy of the program in brain tumor patients after resective surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedFebruary 13, 2018
October 1, 2017
4 years
September 5, 2017
February 12, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Change in objective cognitive functioning
Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs
3, 6, and 12 months after surgery
Change in working memory
Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)
3, 6, and 12 months after surgery
Change in word fluency
Word fluency is measured with the Letter Fluency test
3, 6, and 12 months after surgery
Secondary Outcomes (8)
Change in subjective cognitive functioning
3, 6, and 12 months after surgery
Change in symptoms of fatigue
3, 6, and 12 months after surgery
Change in symptoms of anxiety
3, 6, and 12 months after surgery
Change in symptoms of depression
3, 6, and 12 months after surgery
Change in subjective executive functioning
3, 6, and 12 months after surgery
- +3 more secondary outcomes
Study Arms (2)
Early-intervention group
EXPERIMENTALPatients 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.
Waiting-list control group
OTHERThe waiting-list control group will be offered the same cognitive rehabilitation program after they have undergone all study assessments one year after surgery.
Interventions
Cognitive rehabilitation, i.e. psychoeducation, strategy training \& retraining
Eligibility Criteria
You may qualify if:
- The adult patient has a (supratentorial or infratentorial) brain tumor that is radiologically suspect for either a meningioma or low grade glioma
- The patient will undergo resective surgery for the brain tumor
You may not qualify if:
- tumor resection in the last year
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elisabeth-TweeSteden Ziekenhuislead
- Tilburg Universitycollaborator
- ZonMw: The Netherlands Organisation for Health Research and Developmentcollaborator
- Erasmus Medical Centercollaborator
- Medical Center Haaglandencollaborator
Study Sites (3)
Erasmus Medical Center
Rotterdam, Netherlands
Medical Center Haaglanden
The Hague, Netherlands
Elisabeth-TweeSteden Hospital
Tilburg, 5022 GC, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Well-trained research assistants, who are conducting neuropsychological assessments, are blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2017
First Posted
December 14, 2017
Study Start
July 1, 2015
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
February 13, 2018
Record last verified: 2017-10