Clinical trial · Observational
Validation of the European Oncology Quality of Life Toolkit
Validation of the European Oncology Quality of Life Toolkit. A European Pilot Survey.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Palliative Care | — | UNRESOLVED | — |
| Survivorship | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of the EUonQoL-Kit - Active Treatment questionnaire | Other | — | UNRESOLVED |
| Administration of the EUonQoL-Kit - Palliative Care questionnaire | Other | — | UNRESOLVED |
| Administration of the EUonQoL-Kit - Survivors questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- A) EUonQoL-Kit - Active Treatment module
- description
- EUonQoL-Kit questionnaire specifically designed and administered to patients undergoing/having recently completed curative treatment for early-stage cancers OR undergoing/having recently completed non-curative treatment for advanced or metastatic cancers, including disease controlling/life prolonging tumour-directed treatment.
- interventionNames
- Other: Administration of the EUonQoL-Kit - Active Treatment questionnaire
- label
- B) EUonQoL-Kit - Survivors module
- description
- EUonQoL-Kit questionnaire specifically designed and administered to people being disease-free without evidence of active cancer, and at least one year off active treatment (with the exception of long-term adjuvant hormonotherapy).
- interventionNames
- Other: Administration of the EUonQoL-Kit - Survivors questionnaire
- label
- C) EUonQoL-Kit - Palliative Care module
- description
- EUonQoL-Kit questionnaire specifically designed and administered to patients with advanced cancers with projected prognosis \<12 months and Eastern Cooperative Oncology Group (ECOG) ≥2 OR referred to a specialist palliative care team for symptom control, OR receiving non-curative systemic treatment or radiotherapy purely for symptom control.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Cognitive impairment preventing the completion of the questionnaire
References
Publications (24)
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