Validation of the European Oncology Quality of Life Toolkit

Summary

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

• Cancer
• Survivorship
• Palliative Care

Interventions

OTHER

Administration of the EUonQoL-Kit - Active Treatment questionnaire

Electronic questionnaire to be administered to patients in active treatment.

OTHER

Administration of the EUonQoL-Kit - Survivors questionnaire

Electronic questionnaire to be administered to cancer survivors.

OTHER

Administration of the EUonQoL-Kit - Palliative Care questionnaire

Electronic questionnaire to be administered to patients in palliative care.

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• German Cancer Research Center

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• The Netherlands Cancer Institute

  collaborator OTHER

• Hospital del Mar Research Institute

  collaborator UNKNOWN

• Istituto Europeo di Oncologia

  collaborator OTHER

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• UNICANCER

  collaborator OTHER

• EAPC

  collaborator UNKNOWN

• Institut Curie

  collaborator OTHER

• EUROPEAN CANCER ORGANISATION

  collaborator UNKNOWN

• DIGICORE/IFO

  collaborator UNKNOWN

• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

  collaborator NETWORK

• Alleanza Contro il Cancro

  collaborator OTHER

• Istituti Fisioterapici Ospitalieri

  collaborator OTHER

• STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG

  collaborator UNKNOWN

• University of Milan

  collaborator OTHER

• SporeData OÜ

  collaborator UNKNOWN

• ORGANISATION OF EUROPEAN CANCER INSTITUTES

  collaborator UNKNOWN

• FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA

  collaborator UNKNOWN

• Medical University Innsbruck

  collaborator OTHER

• SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI

  collaborator UNKNOWN

• FEDERATIA ASOCIATIILOR BOLNAVILOR DE CANCER

  collaborator UNKNOWN

• University of Leeds

  collaborator OTHER

• The Leeds Teaching Hospitals NHS Trust

  collaborator OTHER

• Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet)

  collaborator UNKNOWN

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Cinzia Brunelli, PhD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-31

Primary Completion

2024-10-31

Completion

2024-10-31

Countries

• Albania
• Austria
• Belgium
• Bulgaria
• Croatia
• Cyprus
• Czechia
• Denmark
• Estonia
• Finland
• France
• Georgia
• Germany
• Greece
• Hungary
• Ireland
• Italy
• Latvia
• Lithuania
• Moldova
• Netherlands
• Norway
• Poland
• Portugal
• Romania
• Serbia
• Slovakia
• Slovenia
• Spain
• Sweden
• Turkey (Türkiye)
• United Kingdom

Study Locations