Cognitive Impairment Clinical Trial
Official title:
Cognitive Rehabilitation in Brain Tumor Patients After Neurosurgery
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.
Status | Recruiting |
Enrollment | 115 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Erasmus Medical Center | Rotterdam | |
Netherlands | Medical Center Haaglanden | The Hague | |
Netherlands | Elisabeth-TweeSteden Hospital | Tilburg |
Lead Sponsor | Collaborator |
---|---|
Elisabeth-TweeSteden Ziekenhuis | Erasmus Medical Center, Medical Center Haaglanden, University of Tilburg, ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change in word fluency | Word fluency is measured with the Letter Fluency test | 3, 6, and 12 months after surgery | |
Secondary | Change in subjective cognitive functioning | Subjective cognitive functioning is measured with the Cognitive Failures Questionnaire (CFQ) | 3, 6, and 12 months after surgery | |
Secondary | Change in symptoms of fatigue | Fatigue is measured with the Multidimensional Fatigue Inventory (MFI) | 3, 6, and 12 months after surgery | |
Secondary | Change in symptoms of anxiety | Anxiety is measured with the Hospital Anxiety and Depression Scale (HADS) | 3, 6, and 12 months after surgery | |
Secondary | Change in symptoms of depression | Depression is measured with the Hospital Anxiety and Depression Scale (HADS) | 3, 6, and 12 months after surgery | |
Secondary | Change in subjective executive functioning | Subjective executive functioning is measured with the Behavior Rating Inventory of Executive Function | 3, 6, and 12 months after surgery | |
Secondary | Change in professional functioning (1) | Professional functioning is measured with the Work Ability Index (WAI) | One day before surgery vs. 12 months after surgery | |
Secondary | Change in professional functioning (2) | Professional functioning is measured with the Work Limitation Questionnaire (WLQ) | One day before surgery vs. 12 months after surgery | |
Secondary | Change in (social) participation | Participation is measured with the Community Integration Questionnaire (CIQ) | One day before surgery vs. 12 months after surgery |
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