Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 115
- Locations
- 4
- Primary Endpoint
- Change in working memory
Study Overview
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.
Detailed Description
OBJECTIVE: To evaluate the immediate and longer-term effects of early cognitive telerehabilitation on cognitive performance and self-reported symptoms/functioning in patients with low-grade gliomas and meningiomas, in a prospective randomized trial.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Well-trained research assistants, who are conducting neuropsychological assessments, are blinded.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in working memory
Time Frame: 3, 6, and 12 months after surgery
Working memory is measured with the subtest Digit Span of the the Wechsler Adult Intelligence Scale (WAIS-III)
Change in objective cognitive functioning
Time Frame: 3, 6, and 12 months after surgery
Objective cognitive functioning is measured with the computerized test battery CNS Vital Signs
Change in word fluency
Time Frame: 3, 6, and 12 months after surgery
Word fluency is measured with the Letter Fluency test
Secondary Outcomes
- Change in symptoms of fatigue(3, 6, and 12 months after surgery)
- Change in subjective cognitive functioning(3, 6, and 12 months after surgery)
- Change in professional functioning (1)(One day before surgery vs. 12 months after surgery)
- Change in professional functioning (2)(One day before surgery vs. 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)
- Change in (social) participation(One day before surgery vs. 12 months after surgery)