benign primary brain tumor Meningioma
Conditions
Interventions
Health-related quality of life
Meningioma
PROM
Questionnaire
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject should: 1. be diagnosed clinically or histopathologically with a WHO grade 1 meningioma 2. be 18 years or older 3. give written informed consent prior to inclusion
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Patients with a neurofibromatosis type 2 meningioma. 2. Patients not fluent in Dutch, English or Italian (depending on the country where they live). 3. Patients with physical or mental conditions interfering with the understanding and completion of questions and questionnaires.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Development of a meningioma specific PROM, measuring HRQoL Phase 1, generation of relevant HRQoL issues - An exhaustive list of HRQoL issues. Phase 2, construction of an item list - An item list with questions with the same format and time frame as the EORTC questionnaires. Phase 3, pre-testing the provisional questionnaire - Scores on the items of the provisional questionnaire. - Results of preliminary psychometric testing (Factor Analysis, Internal consistency and descriptive statistics). - A preliminary questionnaire. Part B: Validation of a meningioma specific PROM, measuring HRQoL Phase 4, large scale field testing - Scores of *300 patients of the preliminary questionnaire and normative data of the questionnaire based on these data. - Validity, reliability, responsiveness and interpretability. - Scores on the following questionnaires: EORTC QLQ-C30 and QLQ-BN20 and the SF-36. | — |
Countries
Italy, Netherlands, United States of America
Outcome results
None listed