Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey
Abstract Background European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and cultur...
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2024-12-01
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| author | G. Apolone M. Costantini L. Caselli N. Bos A. Caraceni G. Ciliberto N. Couespel M. Ferrer M. Groenvold S. Kaasa C. Lombardo R. Pietrobon G. Pravettoni A. Sirven H. Vachon G. Velikova O. Garin A. Gilbert A. Machiavelli C. Marzorati R. Miceli M. Pe MA. Petersen A. Tanzilli F. van Schelven C. Dantas I Minnée-van Braak L. Pinnavaia C. Brunelli |
| author_facet | G. Apolone M. Costantini L. Caselli N. Bos A. Caraceni G. Ciliberto N. Couespel M. Ferrer M. Groenvold S. Kaasa C. Lombardo R. Pietrobon G. Pravettoni A. Sirven H. Vachon G. Velikova O. Garin A. Gilbert A. Machiavelli C. Marzorati R. Miceli M. Pe MA. Petersen A. Tanzilli F. van Schelven C. Dantas I Minnée-van Braak L. Pinnavaia C. Brunelli |
| author_sort | G. Apolone |
| collection | DOAJ |
| description | Abstract Background European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries. Methods A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test–retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL. Discussion The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe. Trial registration ClinicalTrials.gov Identifier: NCT05947903, 2023–06-28. |
| format | Article |
| id | doaj-art-d443309d11a747d9930fd06429e2d686 |
| institution | OA Journals |
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| publishDate | 2024-12-01 |
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| spelling | doaj-art-d443309d11a747d9930fd06429e2d6862025-08-20T02:31:39ZengBMCBMC Public Health1471-24582024-12-0124111210.1186/s12889-024-21008-4Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European surveyG. Apolone0M. Costantini1L. Caselli2N. Bos3A. Caraceni4G. Ciliberto5N. Couespel6M. Ferrer7M. Groenvold8S. Kaasa9C. Lombardo10R. Pietrobon11G. Pravettoni12A. Sirven13H. Vachon14G. Velikova15O. Garin16A. Gilbert17A. Machiavelli18C. Marzorati19R. Miceli20M. Pe21MA. Petersen22A. Tanzilli23F. van Schelven24C. DantasI Minnée-van BraakL. Pinnavaia25C. Brunelli26Fondazione IRCCS Istituto Nazionale dei TumoriFondazione IRCCS Istituto Nazionale dei TumoriFondazione IRCCS Istituto Nazionale dei TumoriNetherlands Institute for Health Services Research (Nivel)Dipartimento di Scienze Cliniche e di Comunità, Università degli Studi di MilanoIRCCS Istituto Nazionale dei Tumori Regina ElenaEuropean Cancer Organisation (ECO)Health Services Research Group, Hospital del Mar Research InstituteDepartment of Public Health, Bispebjerg Hospital and University of CopenhagenDepartment of Oncology, Oslo University HospitalOrganisation of European Cancer Institutes (OECI-EEIG)SporeData OÜApplied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCSUnicancerEuropean Organisation for Research and Treatment of Cancer (EORTC)Leeds Institute of Medical Research at St James’s, University of LeedsHealth Services Research Group, Hospital del Mar Research InstituteLeeds Institute of Medical Research at St James’s, University of LeedsSporeData OÜApplied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCSFondazione IRCCS Istituto Nazionale dei TumoriEuropean Organisation for Research and Treatment of Cancer (EORTC)Palliative Care Research Unit, Department of Geriatrics and Palliative Medicine GP, Bispebjerg and Frederiksberg Hospital, University of CopenhagenIRCCS Istituto Nazionale dei Tumori Regina ElenaNetherlands Institute for Health Services Research (Nivel)Department of Languages, Literatures, Cultures and Mediation, University of MilanFondazione IRCCS Istituto Nazionale dei TumoriAbstract Background European cancer programmes and policies lack a unified health-related quality of life (HRQoL) assessment tool. The European oncology quality of life toolkit (EUonQoL-Kit) is a novel set of HRQoL questionnaires, co-designed with cancer patients and survivors, translated and culturally adapted into 31 European languages, and with both static and dynamic electronic administration modes. The main aim of this study is the psychometric assessment of the static version. Secondary aims include evaluating the EUonQoL-Kit acceptability, cross-validating the administration modes, exploring individual factors potentially affecting HRQoL and HRQoL inequalities between countries. Methods A sample of 4,500 participants, including three groups (active treatment, survivors, and palliative care) from 45 centres in 25 EU Member States and 7 associated countries, will be enrolled in a multicentre observational cross-sectional study. All participants will complete the static EUonQoL-Kit; three subsamples (each 10% of the total sample) will also respectively complete the following: a) dynamic EUonQoL-Kit, based on Item Response Theory (IRT)/Computer Adaptive Testing (CAT), b) FACT-G and EQ-5L-5D, and c) static EUonQoL-Kit (re-test). Psychometric analyses will encompass exploratory and confirmatory factor analyses (measurement model and structural validity), Cronbach's alpha (internal consistency), intraclass correlation coefficient (test–retest reliability), Pearson/Spearman correlation (concurrent validity), comparison of group scores (construct validity), and Differential Item Functioning (cross-country item equivalence). Secondary analyses will evaluate participant response time and rate, and static/dynamic score differences. Regression models will estimate associations between individual factors and HRQoL. Discussion The EUonQoL-Kit will serve to systematically incorporate patient perspectives into European cancer policies and to address HRQoL inequalities across Europe. Trial registration ClinicalTrials.gov Identifier: NCT05947903, 2023–06-28.https://doi.org/10.1186/s12889-024-21008-4NeoplasmsHealth-Related Quality of LifePatient Reported Outcome MeasureTreatment Related CancerPalliative CareCancer Survivor |
| spellingShingle | G. Apolone M. Costantini L. Caselli N. Bos A. Caraceni G. Ciliberto N. Couespel M. Ferrer M. Groenvold S. Kaasa C. Lombardo R. Pietrobon G. Pravettoni A. Sirven H. Vachon G. Velikova O. Garin A. Gilbert A. Machiavelli C. Marzorati R. Miceli M. Pe MA. Petersen A. Tanzilli F. van Schelven C. Dantas I Minnée-van Braak L. Pinnavaia C. Brunelli Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey BMC Public Health Neoplasms Health-Related Quality of Life Patient Reported Outcome Measure Treatment Related Cancer Palliative Care Cancer Survivor |
| title | Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey |
| title_full | Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey |
| title_fullStr | Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey |
| title_full_unstemmed | Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey |
| title_short | Validation of the European Oncology toolkit for the self-assessment of Quality of Life (EUonQoL-Kit) in cancer patients and survivors: study protocol of a pan European survey |
| title_sort | validation of the european oncology toolkit for the self assessment of quality of life euonqol kit in cancer patients and survivors study protocol of a pan european survey |
| topic | Neoplasms Health-Related Quality of Life Patient Reported Outcome Measure Treatment Related Cancer Palliative Care Cancer Survivor |
| url | https://doi.org/10.1186/s12889-024-21008-4 |
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