Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,000
- 试验地点
- 45
- 主要终点
- Validity and reliability of the EUonQoL-Kit static version
研究概览
简要总结
The improvement or preservation of quality of life (QoL) is one of the three pillars of the European Union (EU) Mission on Cancer, which underpins the needs of patients from cancer diagnosis throughout treatment, survivorship, and advanced terminal stages. Clinical studies and real-world data show that the use of Patient Reported Outcome Measures (PROMs) for QoL assessment in routine oncology practice has positive effects on patient wellbeing and healthcare resource utilization. However, full implementation of PROMs is not yet part of standard of care and is not adequately considered in cancer policies and programs.
A comprehensive tool incorporating the perspective of patients at different stages of the disease trajectory and widely applicable across Europe is still lacking.
The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL, developed from preferences and priorities of people with past or current cancer experience. The EUonQoL-Kit includes three electronic questionnaires, specifically designed for different disease phases (patients in active treatment, survivors, and patients in palliative care), available in both static and dynamic (Computer Adaptive Testing, CAT) versions and in several European languages.
This is a multicentre observational study, with the following aims:
- The primary aim is to perform the psychometric validation of the EUonQoL-Kit.
- Secondary aims are to assess its acceptability, to validate the static and dynamic versions against each other, and to provide estimates of QoL across European countries.
The EUonQoL-Kit will be administered to a sample of patients from 45 European cancer centres. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C).
Each centre will recruit 100 patients (40 from group A, 30 from group B, 30 from group C), for an overall sample size of 4,500 patients (at least 4,000 patients are assumed to be enrolled, due to an expected lower recruitment rate of 10-15%). Three sub-samples of patients (each corresponding to 10% of the total sample for each centre) will fill in an additional questionnaire:
- FACT-G (Functional Assessment of Cancer Therapy - General) and EQ-5D-5L (5-level European Quality of Life Five Dimension), to test concurrent validity.
- Live-CAT version, to validate the static and dynamic versions against each other.
- EUonQoL-Kit, at least 1 hour after the first completion, to assess test-retest reliability.
详细描述
Several patient-reported questionnaires have been developed and validated to measure quality of life (QoL) of cancer patients. However, a comprehensive tool, developed in close collaboration with people who have experienced cancer, widely applicable across Europe and tailored to the health status of the individual patient, is lacking. Such a tool will be important for incorporating the patient's perspective into the evaluation of policies and programs addressing cancer at the European level.
The European Oncology Quality of Life Toolkit (EUonQoL-Kit) is a unified patient-centred tool for the assessment of QoL based on preferences of cancer patients and survivors. It is developed from a patient perspective, administered digitally, available in the languages of the European Union (EU) 27 and several associated countries, and applicable in future surveys to contribute to the EU's mission on cancer. It includes three static questionnaires specifically developed for different disease phases (patients in active treatment, survivors, and patients in palliative care), and three dynamic versions of the same questionnaires based on Item Response Theory (IRT) and Computer Adaptive Testing (CAT).
This is an observational study aimed to perform the psychometric validation of the EUonQoL-Kit through its first large scale application in a pan European pilot survey.
The EUonQoL-Kit will be tested in a sample of cancer patients and survivors from 45 oncological centres located in 33 European countries. The sample will include patients in active treatment (group A), survivors (group B), and patients in Palliative Care (group C). Each centre will recruit a sample of 100 participants (40 from group A, 30 from group B, 30 from group C), stratified for primary diagnosis: lung cancer, breast cancer, colorectal cancer, haematological malignancies, prostate cancer, others.
In each centre, data collection will be performed in pre-identified outpatient clinics and inpatient wards. Participation in the study will be offered to eligible patients until the pre-defined sample size is reached.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Age 18 years or more.
- •Present or past histologically confirmed diagnosis of solid tumour or haematological malignancy.
- •Being in one of these three conditions: A) Patients in active treatment; B) Survivors; C) in Palliative Care.
- •Native tongue or fluent in the language of the questionnaire
- •Written informed consent to the study.
排除标准
- •Cognitive impairment preventing the completion of the questionnaire
结局指标
主要结局
Validity and reliability of the EUonQoL-Kit static version
时间窗: All assessments at time of administration of the questionnaires, apart reproducibility that will be assessed with a re-test at least after 1 hour for all patients
Exploratory and confirmatory factor analyses, distribution of the scales' scores, reliability in terms of internal consistency and reproducibility, concurrent and construct validity, differential item functioning.
次要结局
- Assessment of Quality of Life (QoL) inequalities across clusters of European populations, countries, and healthcare systems, using EUonQoL-Kit questionnaires(At day 1)
- Validation of the EUonQoL-Kit dynamic (CAT) version(At day 1)
- Socio-demographic and clinical factors potentially associated with QoL(At day 1)
- Acceptability of the EUonQoL-Kit(At day 1)