Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborator:
Gustave Roussy, Cancer Campus, Grand Paris, DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG (German Cancer Research Center), Oslo universitetssykehus HF, The Netherlands Cancer Institute, Hospital del Mar Research Institute, Istituto Europeo di Oncologia, European
Studienleiter
Cinzia Brunelli, PhD Principal Investigator Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
E-Mail: cinzia.brunelli@istitutotumori.mi.it» Ansprechpartner anzeigenIstituto Nazionale Tumori Regina Elena 00144 Roma Italy» Google-MapsRiga East University Hospital LV-1038 Riga Latvia» Google-MapsNational Cancer Institute 08406 Vilnius Lithuania» Google-Maps Ansprechpartner: Audrius Dulskas, Dr» Ansprechpartner anzeigenOncologic Institute of Moldova MD-2025 Chisinau Moldova, Republic of» Google-Maps Ansprechpartner: Vadim Pagonet, DR» Ansprechpartner anzeigenNetherlands Cancer Institute 1066 CX Amsterdam Netherlands» Google-Maps Ansprechpartner: Lonneke van de Poll, Prof» Ansprechpartner anzeigenOslo University Hospital (OUS) 0450 Oslo Norway» Google-Maps Ansprechpartner: Marianne Grønlie Guren, Prof» Ansprechpartner anzeigenGreater Poland Cancer Centre 61-866 Poznań Poland» Google-Maps Ansprechpartner: Maria Litwiniuk, Prof» Ansprechpartner anzeigenNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy 02-781 Warsaw Poland» Google-Maps Ansprechpartner: Iwona Lugowska» Ansprechpartner anzeigenInstituto Português de Oncologia do Porto Francisco Gentil, E.P.E. (IPO-Porto) 4200-072 Porto Portugal» Google-MapsInstitutul Oncologic "Al. Trestioreanu" (IOB) 022328 Bucharest Romania» Google-MapsThe "Prof. Dr. Ion Chiricuta"Institute of Oncology (IOCN) 400015 Cluj-Napoca Romania» Google-Maps Ansprechpartner: Tudor Ciuleanu, Prof» Ansprechpartner anzeigenOncology Institute of Vojvodina 21204 Sremska Kamenica Serbia» Google-Maps Ansprechpartner: Milana Mitric Askovic, Dr» Ansprechpartner anzeigenNational Cancer Institute (Národný onkologický ústav) 83310 Bratislava Slovakia» Google-Maps Ansprechpartner: Michal Chovanec, Prof» Ansprechpartner anzeigenOnkološki Inštitut Ljubljana 1000 Ljubljana Slovenia» Google-MapsVall Hebron Institute of Oncology (VHIO) 08035 Barcelona Spain» Google-Maps Ansprechpartner: Maria Vieito, Dr» Ansprechpartner anzeigenFundacion Jimenez Diaz University Hospital 28040 Madrid Spain» Google-MapsFundación Instituto Valenciano de Oncología (IVO) 46009 Valence Spain» Google-MapsSahlgrenska comprehensive cancer centre 413 45 Gothenburg Sweden» Google-MapsAnadolu Medical Center 41400 Gebze Turkey» Google-MapsTurkey Cancer Institute 34718 Istanbul Turkey» Google-Maps Ansprechpartner: Mahmut Gumus, Prof» Ansprechpartner anzeigenLeeds Teaching Hospitals NHS Trust LS1 3EX Leeds United Kingdom» Google-Maps Ansprechpartner: Alexandra Gilbert, Dr» Ansprechpartner anzeigen
1. Validity and reliability of the EUonQoL-Kit static version (Time Frame - All assessments at time of administration of the questionnaires, apart reproducibility that will be assessed with a re-test after 7 days (± 1) for patients in active treatments and survivors, and after 2 days (± 1) for patients in palliative care): 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.
Secondary outcome:
1. Acceptability of the EUonQoL-Kit (Time Frame - At day 1): Acceptability of the EUonQoL-Kit and reasons for refusal, including patient burden in filling in the questionnaire
2. Validation of the EUonQoL-Kit dynamic (CAT) version (Time Frame - At day 1): Comparison of the scores obtained with the static and dynamic versions to test if they produce similar, interchangeable results; assessment to test whether the items selected for the static version and the related CAT-settings should be adjusted to obtain optimal assessment.
3. Assessment of Quality of Life (QoL) inequalities across clusters of European populations, countries, and healthcare systems, using EUonQoL-Kit questionnaires (Time Frame - At day 1): Analysis of the QoL scores (dependent variable) according to individual-level variables as well as country/health system level variables (independent variables)
4. Socio-demographic and clinical factors potentially associated with QoL (Time Frame - At day 1): Assessment of QoL disparities across different patient groups (by gender, ethnicity, religion, area, psychological and socio-economic factors, and education level)
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.
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).
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.