meningioma Primary brain tumor
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: (1) Adult patients, must be over 18 years old; (2) Patients with a histologically confirmed or suspected intracranial meningioma; (3) The end of the primary anti-tumor treatment was at least 5 years prior to inclusion. ;Every participant will be asked if there is an informal caregiver available to participate as well. They are: (1) Adults; over 18 years old; (2) The spouse, family member, or close friend of the patient; (3) They provide the majority of emotional and physical support to the patient.
Exclusion criteria
Exclusion criteria: Patients: (1) Currently receiving anti-tumor treatment; (2) Having received whole-brain radiation for a disease other than a confirmed or suspected intracranial meningioma; (3) Diagnosed with neurofibromatosis type 2; (4) Diagnosed with a neurodegenerative disease influencing their cognitive abilities; (5) Incompetent and not having a legal representative to provide consent to study participation on their behalf; (6) Insufficient understanding of the Dutch language; (7) Not signed informed consent.;Informal caregivers: (1) Insufficient understanding of the Dutch language; (2) Diagnosed with a neurodegenerative disease influencing their cognitive abilities; (3) The patient does not sign informed consent; (4) No signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Neurocognitive functioning. This will be assessed with a comprehensive test battery consisting of the following validated neuropsychological tests: - The Rey Auditory Verbal Learning Test - The Concept Shifting Test - The Memory Comparison Test - Categoric Word Fluency Test - The Digit-Symbol Substitution Test - The Stroop Colour-Word Test 2) Health-related quality of life - Medical OUtcomes Study (MOS) Short-Form Health Survey (SF-36) questionnaire - European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 questionnaire 3) Level of work productivity - Short Form - Health and Labor Questionnaire 4) Health resource utilization - study-specific questionnaire 5) Caregiver burden - Caregiver Burden Scale (CBS) 6) Anxiety and depression - Hospital Anxiety and Depression Scale (HADS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following patient characteristics will be retrieved from the medical records: age, gender, tumor characteristics, Karnofsky Performance Status (KPS), neurological and cognitive functioning (if available), date of diagnosis/PA, number of seizures in the last three months, the received treatment (surgery/radiotherapy and supportive treatment) from diagnosis, and complications after treatment. A study-specific questionnaire will include the following items: level of education, current or last profession and comorbidity. The following characteristics of informal caregivers will be assessed with a study-specific questionnaire and will include: age, gender, level of education, current or last profession, relation to the patient and comorbidity. | — |
Countries
Netherlands
Outcome results
None listed