Apolone, G.
Costantini, M.
Caselli, L.
Bos, N.
Caraceni, A.
Ciliberto, G.
Couespel, N.
Ferrer, M.
Groenvold, M.
Kaasa, S.
Lombardo, C.
Pietrobon, R.
Pravettoni, G.
Sirven, A.
Vachon, H.
Velikova, G.
Garin, O.
Gilbert, A.
Machiavelli, A.
Marzorati, C.
Miceli, R.
Pe, M.
Petersen, MA.
Tanzilli, A.
van Schelven, F.
Dantas, C.
Minnée-van Braak, I
Pinnavaia, L.
Brunelli, C.
Article History
Received: 6 August 2024
Accepted: 6 December 2024
First Online: 18 December 2024
Declarations
:
: The survey will be performed in line with the principles of the Declaration of Helsinki and the ethical principles of observational research on potentially fragile patients []. The study was approved by the Ethics Committee (EC) of the coordinating centre (Fondazione IRCCS Istituto Nazionale Tumori di Milano): Comitato Etico Territoriale Lombardia 4, approval number INT 106/23. All 45 clinical centres have received ethical approval from their local EC, with the list of approving ECs and associated approval numbers provided in Additional file 2. A detailed list of the clinical centres participating in the study is published on Clinicaltrials.gov (study ID: NCT05947903) and each centre's approval package is published on the project website as deliverable D7.2 []). Written informed consent will be obtained from all individuals participating in the study. Study-specific ethics approval and informed consent statements are available in Supplementary Information 3, Additional File 1. Data will be managed and curated in accordance with the EU regulation 2016/679. Study-specific statements concerning data management and confidentiality are reported in Supplementary Information 4, Additional File 1.
: Not applicable.
: Authors MP, NB, CB, AT, AS, AG, AM, RP, CL, FVS, LC, MC, GA, CM, and NC declare they have no financial interests except for project funding from the European Commission (G.A.: 101096362 – EUonQoL) to their Institution. AC has received teaching course honoraria from Molteni and Mundipharma, and project funding from the European Commission (G.A.: 101096362 – EuonQoL) to his Institution. MAP has received project funding and travel support from the European Commission (G.A.: 101096362 – EuonQoL) to his Institution. RM has received consulting fees from Boheringer and project funding from the European Commission (G.A.: 101096362 – EuonQoL) to her Institution. GV has received: travel support from Pfizer and Roche (not related to this manuscript); research funding from NIHR Programme Grant, NIHR Programme Development Grant, Pfizer, Yorkshire Cancer Research to her Institution; consulting fees not related to this manuscript from Pfizer, Roche, Seagen; honoraria for lectures and speakers from Pfizer, Roche, Novartis, Eisai and Sanofi (not related to this manuscript); GV declares relationship with EORTC Board of Directors and NCRI Chair of Living with and Beyond Cancer (not related to this manuscript) and has served on advisory boards for Roche, Seagen, Astra Zeneca (not related to this manuscript). GP declares Grants to her Institution and project funding and travel support from the European Commission (G.A.: 101096362 – EuonQoL) to her Institution. MG declares project funding from the European Commission (G.A.: 101096362 – EuonQoL) and grants from EORTC to his Institution. OG declares project funding from the European Commission (G.A.: 101096362 – EuonQoL) to her Institution and a contract with Instituto de Salud Carlos III (PI21/00026). SK declares project funding from the European Commission (G.A.: 101096362 – EuonQoL) to his Institution and the role of Scientific Advisory Board for Norwegian Cancer Society. GC declares project funding and travel support to his Institution from the European Commission (G.A.: 101096362 – EuonQoL), AIRC, Italian Ministry of Health and Italian Ministry of Research; he also declares stock options from Neomatrix Srl and the following patents: WO2019/198115, PCT/IT2023/050171, EP 3795593 A1. Authors CD, IM, LP declare they have no competing interests.