Brain tumor primary brain tumor (glioma) and metastatic brain tumor
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Pilot study (1) Adults; patients and their proxies must be over 18 years. (2) Patients with histologically confirmed low- or high-grade glioma; WHO grade II diffuse astrocytoma, oligodendroglioma or oligoastrocytoma, WHO grade III anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma, or WHO grade IV glioblastoma, and their proxies. (3) The intensity of contact of the proxy with the patient should be in such a way that the proxy clearly knows how the patient is functioning in daily life (daily or weekly contact).;Main study (1) Adults; patients and their proxies must be over 18 years. (2) a. Patients with histologically confirmed low- or high-grade glioma; WHO grade II diffuse astrocytoma, oligodendroglioma or oligoastrocytoma, WHO grade III anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma, or WHO grade IV glioblastoma, and their proxies. b. Patients with a metastatic brain tumor and a histologically confirmed primary tumor, and their proxies. (3) The intensity of contact of the proxy with the patient should be in such a way that the proxy clearly knows how the patient is functioning in daily life (daily or weekly contact).
Exclusion criteria
Exclusion criteria: Main study (1) Patients and proxies without understanding of the official language of the country in which they live.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilot study Study parameters including: - Item selection and generation, resulting in a provisional item list to measure IADL in patients with a brain tumor. Main study Study parameters including: - Item selection and generation, resulting in an item list that will be pre-tested and field tested for psychometric properties, acceptability and cross-cultural applicability in a large international population of brain tumor patients. - Psychometric properties (of both versions of the questionnaire) such as validity, reliability and responsiveness. - Measures of agreement between patient and proxy ratings. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot study Baseline characteristics including: - Patient: age, gender, level of education, tumor type and grade, Karnofsky Performance Score (KPS), cognitive functioning (if available), date of diagnosis, treatment. - Proxy: age, gender, level of education, relation to the patient, duration relationship, intensity of contact with the patient. Main study Baseline characteristics including: - Patient: age, gender, level of education, Karnofsky Performance Score (KPS), cognitive functioning (if available), status disease, current treatment, previous treatments, Specifically for primary brain tumor: tumor type and grade, date of diagnosis, date of recurrence, and for metastatic brain tumor: number of metastases, type of primary tumor, date of diagnosis primary tumor and date of diagnosis brain metastasis. - Proxy: age, gender, level of education, relation to the patient, duration relationship, intensity of contact with the patient. | — |
Countries
Netherlands
Outcome results
None listed