Revision of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-BN20 Brain Tumour Module
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Number of relevant items of the EORTC QLQ-BN101
研究概览
简要总结
Despite the fact that use of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Brain Neoplasm (QLQ-BN20) has tremendously contributed to insight into the health-related quality of life (HRQoL) of brain tumor patients, certain items of the questionnaire have raised issues, and new treatments have been introduced, with different toxicity profiles not covered by the current measure. These observations have led to the recognition that a revision of the QLQ-BN20 is warranted.
The aim of this project is to update the current EORTC QLQ-BN20 questionnaire.
详细描述
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Brain Neoplasm (QLQ-BN20) brain tumor module was developed and validated in 1996, with a phase IV validation in 2010. The aim of this module was to evaluate the effects of the tumor and its treatment on symptoms, functions and health-related quality of life (HRQoL) of brain tumor patients, both in clinical trials and clinical practice.
An unpublished systematic review conducted by our group revealed that since the publication of the QLQ-BN20 in 1996, there has been an increase in the use of this questionnaire, not only in glioma patients for whom this questionnaire was developed, but also in meningioma patients, patients with brain metastases or groups with mixed types of brain tumors. The use of the QLQ-BN20 showed an increase over time: from 20 publications in the period 1996-2006, to 98 publications in the period 2007-2016.
One of the reasons for updating the current QLQ-BN20 questionnaire is that were have encountered limitations in the use of specific items. For example, the item referring to the occurrence of seizures results in an underestimation of the true prevalence of seizures. In previous clinical studies it was shown that 30-60% of the brain tumor patients experience seizures. In contrast, large randomized controlled trials using the QLQ-BN20 to determine seizure occurrence showed prevalences of only 6 to 14 percent. This is probably due to the time frame that is used for this item, i.e. the 'last week'. Although seizures are frequent, they often do not occur weekly. With the current response format, detection of seizures is difficult and this should be taken into account in the revision of the QLQ-BN20 questionnaire. Second, several items show severe floor-effects. Probably the most important reason to revise the current QLQ-BN20 questionnaire is because major advances in the treatment of brain tumors have been made in the last 20 years. Compared to 20 years ago, when the QLQ-BN20 was developed, current standard treatment (multimodal treatment including surgery, radiotherapy and chemotherapy) is different and treatments have a different toxicity profile. Moreover, new treatment opportunities are currently explored and include targeted treatment and immunotherapy. These types of treatment bring new toxicities, e.g. eye, skin and endocrine function problems. The current brain tumor module lacks sufficient coverage of domains that are affected by current and new treatment options.
Thus, despite the fact that use of the QLQ-BN20 has tremendously contributed to insight into the quality of life of brain tumor patients, several observations have led to the recognition that a revision of the QLQ-BN20 is warranted. Therefore, the aim of this project is to update the current EORTC QLQ-BN20 questionnaire.
Aim: The overall aim of this study is to update the current EORTC QLQ-BN20 questionnaire for use in brain tumor patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven or suspected diffuse astrocytoma (Isocitrate Dehydrogenase-1 (IDH-1) wildtype or IDH-1 mutated), diffuse oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), anaplastic astrocytoma (IDH-1 wildtype or IDH-1 mutated), anaplastic oligodendroglioma (IDH-1 mutated and 1p/19q co-deleted), glioblastoma (IDH-1 wild-type or IDH-1 mutated), or diffuse astrocytoma not otherwise specified (NOS), anaplastic astrocytoma NOS, oligodendroglioma NOS, oligoastrocytoma NOS, anaplastic oligoastrocytoma NOS, anaplastic oligodendroglioma NOS or glioblastoma NOS; or radiologically verified metastatic brain tumour.
- •Adult patients: ≥18 years of age
- •Willing to provide written informed consent
排除标准
- •Patients without understanding of the official language of the country in which they live.
- •Patients with any psychiatric condition or cognitive impairment, as determined by the treating physician, that would hamper undergoing semi-structured interviews.
结局指标
主要结局
Number of relevant items of the EORTC QLQ-BN101
时间窗: Baseline
Construction of the final item list, based on predefined decision rules
次要结局
- Discriminant validity(Baseline)
- Internal consistency(Baseline)
- Convergent validity(Baseline)
- Number of multi-item and single-item scales(Baseline)
研究者
LindaDirven
Principal Investigator
Leiden University Medical Center