Validation of the European Oncology Quality of Life Toolkit

NCT05947903 | Not Yet Recruiting

• 1 other identifier: INT 106/23
• Study Type: observational
• Target: 4,000
• Locations: 29 countries
• Sites: 40

Brief 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

Keywords

Quality of life; cancer; questionnaire; validation; survivorship; palliative care; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• Validity and reliability of the EUonQoL-Kit static version

  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.

  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

Secondary Outcomes (4)

• Acceptability of the EUonQoL-Kit

  At day 1

• Validation of the EUonQoL-Kit dynamic (CAT) version

  At day 1

• Assessment of Quality of Life (QoL) inequalities across clusters of European populations, countries, and healthcare systems, using EUonQoL-Kit questionnaires

  At day 1

• Socio-demographic and clinical factors potentially associated with QoL

  At day 1

Study Arms (3)

A) EUonQoL-Kit - Active Treatment module

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.

Other: Administration of the EUonQoL-Kit - Active Treatment questionnaire

B) EUonQoL-Kit - Survivors module

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).

Other: Administration of the EUonQoL-Kit - Survivors questionnaire

C) EUonQoL-Kit - Palliative Care module

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.

Other: Administration of the EUonQoL-Kit - Palliative Care questionnaire

Interventions

Administration of the EUonQoL-Kit - Active Treatment questionnaire OTHER

Electronic questionnaire to be administered to patients in active treatment.

A) EUonQoL-Kit - Active Treatment module

Administration of the EUonQoL-Kit - Survivors questionnaire OTHER

Electronic questionnaire to be administered to cancer survivors.

B) EUonQoL-Kit - Survivors module

Administration of the EUonQoL-Kit - Palliative Care questionnaire OTHER

Electronic questionnaire to be administered to patients in palliative care.

C) EUonQoL-Kit - Palliative Care module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in one of the following three conditions will be screened for their eligibility: A) In active treatment: Undergoing or recently completed curative treatment for early-stage cancers OR undergoing or recently completed non-curative treatment for ad-vanced or metastatic cancers, including disease controlling/life prolonging tumour-directed treatment. B) Survivors: Being disease-free without evidence of active cancer, and at least one year off active treatment (with the exception of long-term adjuvant hormonotherapy). C) Palliative Care (PC): patients with advanced cancers with projected prognosis \<12 months and 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.

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment preventing the completion of the questionnaire

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• German Cancer Research Center: collaborator
• Oslo University Hospital: collaborator
• The Netherlands Cancer Institute: collaborator
• Hospital del Mar Research Institute: collaborator
• Istituto Europeo di Oncologia: collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• UNICANCER: collaborator
• EAPC: collaborator
• Institut Curie: collaborator
• EUROPEAN CANCER ORGANISATION: collaborator
• DIGICORE/IFO: collaborator
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator
• Alleanza Contro il Cancro: collaborator
• Istituti Fisioterapici Ospitalieri: collaborator
• STICHTING NEDERLANDS INSTITUUT VOOR ONDERZOEK VAN DE GEZONDHEIDSZORG: collaborator
• University of Milan: collaborator
• SporeData OÜ: collaborator
• ORGANISATION OF EUROPEAN CANCER INSTITUTES: collaborator
• FEDERAZIONE ITALIANA DELLE ASSOCIAZIONI DI VOLONTARIATO IN ONCOLOGIA: collaborator
• Medical University Innsbruck: collaborator
• SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI: collaborator
• FEDERATIA ASOCIATIILOR BOLNAVILOR DE CANCER: collaborator
• University of Leeds: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Region Hovedstaden (Bispebjerg Hospital & Rigshospitalet): collaborator

Study Sites (45)

Mother Teresa University Hospital

Tirana, 1000, Albania

Location

Comprehensive Cancer Center

Vienna, 10090, Austria

Location

Kortrijk Kankercentrum AZ Groeninge

Kortrijk, 8500, Belgium

Location

Bulgarian Joint Cancer Network

Varna, 9000, Bulgaria

Location

Klinika za tumore Klinički bolnički centar Sestre milosrdnice

Zagreb, 10000, Croatia

Location

Cyprus Association of Cancer Patients and Friends (PASYKAF)

Nicosia, 2000, Cyprus

Location

Masarykův onkologický ústav

Brno, 60200, Czechia

Location

Region Hovedstaden (Rigshospitalet)

Hillerød, 3400, Denmark

Location

North Estonia Medical Centre

Tallinn, 13419, Estonia

Location

Sihtasutus Tartu Ülikooli Kliinikum

Tartu, 50406, Estonia

Location

HUS Syöpäkeskus Helsingin Yliopistollinen Sairaala

Helsinki, 00290, Finland

Location

lnstitut de Cancérologie de l'Ouest (ICO)

Angers, 49055, France

Location

Institut Curie

Paris, 75005, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Petre Shotadze Tbilisi Medical Academy

Tbilisi, 0144, Georgia

Location

Universitäres Centrum für Tumorerkrankungen (UCT)

Frankfurt, 60590, Germany

Location

Deutsches Krebsforschungszentrum (DKFZ)

Heidelberg, 69120, Germany

Location

Comprehensive Cancer Center Munich

Munich, 81377, Germany

Location

General Oncology Hospital of Athens - Saint Savvas

Athens, 11522, Greece

Location

Országos Onkológiai Intézet

Budapest, 1122, Hungary

Location

Trinity St. James's Cancer Institute

Dublin, D08 NHY1, Ireland

Location

Istituto Tumori Giovanni Paolo II, IRCCS

Bari, Italy

Location

Istituto Europeo di Oncologia, IRCCS

Milan, 20121, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Location

Istituto Nazionale Tumori Regina Elena

Roma, 00144, Italy

Location

Riga East University Hospital

Riga, LV-1038, Latvia

Location

National Cancer Institute

Vilnius, 08406, Lithuania

Location

Oncologic Institute of Moldova

Chisinau, MD-2025, Moldova

Location

Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands

Location

Oslo University Hospital (OUS)

Oslo, 0450, Norway

Location

Greater Poland Cancer Centre

Poznan, 61-866, Poland

Location

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy

Warsaw, 02-781, Poland

Location

Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (IPO-Porto)

Porto, 4200-072, Portugal

Location

Institutul Oncologic "Al. Trestioreanu" (IOB)

Bucharest, 022328, Romania

Location

The "Prof. Dr. Ion Chiricuta"Institute of Oncology (IOCN)

Cluj-Napoca, 400015, Romania

Location

Oncology Institute of Vojvodina

Kamenitz, 21204, Serbia

Location

National Cancer Institute (Národný onkologický ústav)

Bratislava, 83310, Slovakia

Location

Onkološki Inštitut Ljubljana

Ljubljana, 1000, Slovenia

Location

Vall Hebron Institute of Oncology (VHIO)

Barcelona, 08035, Spain

Location

Fundación Instituto Valenciano de Oncología (IVO)

Valencia, 46009, Spain

Location

Sahlgrenska comprehensive cancer centre

Gothenburg, 413 45, Sweden

Location

Region Skåne - University Hospital Cancer Centre

Lund, Sweden

Location

Anadolu Medical Center

Gebze, 41400, Turkey (Türkiye)

Location

Turkey Cancer Institute

Istanbul, 34718, Turkey (Türkiye)

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

Location

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Cinzia Brunelli, PhD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Brunelli, PhD

CONTACT

00390223903387; cinzia.brunelli@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 17, 2023
• Study Start: August 31, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-06

Locations

GE (1); SE (1); DK (1); CY (1); FR (3); MO (1); DE (3); SL (1); GR (1); CR (1); LA (1); ES (2); NO (1); FI (1); GB (1); BU (1); AU (1); IE (1); BE (1); HU (1); LI (1); PL (2); PT (1); RO (2); IT (4); AL (1); TU (2); NL (1); CZ (1)