Abstract 708TiP
Background
HNC survivors suffer from high physical, psychological and socioeconomic burdens. Achieving cancer-free survival with an optimal QoL is the primary goal for HNC patients (pts) management. Therefore, maintaining lifelong surveillance is critical. This can be carried out by advanced analysis of environmental, emotional and behavioral data unobtrusively collected from mobile devices. The aim of this clinical trial is to reduce, with specific non-invasive tools (i.e., their mobile devices), the proportion of HNC survivors experiencing a clinically meaningful reduction in QoL during post-treatment follow-up.
Trial design
The BD4QoL study is a multicenter, international, randomized (2:1), open-label, superiority trial. The primary endpoint is defined as a clinically meaningful global health-related EORTC QLQ-C30 QoL deterioration (decrease≥10 points) at any point during 24 months post-treatment follow-up. The sample size is 420 pts. Patients will be randomized to be followed up using the BD4QoL platform or per standard clinical practice. The BD4QoL platform includes a set of services to allow pts monitoring and empowerment through two main tools: the Point of Care dashboard, to manage all of the pts data and follow-up by clinical investigators, and a mobile application (mApp) installed on participating pts’ smartphones, that includes a chatbot for pts e-coaching. Also, a web-form tool is provided to allow the QoL questionnaire completion. Eligibility criteria include completing curative treatments for non-metastatic HNC and the use of an Android-based smartphone. Pts undergoing active treatments or with synchronous cancers are excluded. In both arms, pts will be followed up as per clinical practice, asked to fill in QoL questionnaires at study entry and during follow-up (every 6 months). In the intervention arm (280 pts), pts will, in addition, receive the investigational mApp. In the control arm (140 pts), the study mApp will not be provided to pts.
Clinical trial identification
NCT05315570.
Editorial acknowledgement
Legal entity responsible for the study
Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy (clinical trial sponsor); the whole research project is conducted on behalf of the BD4QoL Consortium.
Funding
European Commission within the call H2020-SC1-DTH-2018-2020 (Digital transformation in Health and Care), topic SC1-DTH-01-2019 (Proposal number 875192).
Disclosure
M. LeBlanc: Financial Interests, Personal, Other, Honoraria, outside of this study: MSD. C. Resteghini: Financial Interests, Personal, Invited Speaker: SunPharma. D.E. Filippidou: Financial Interests, Personal, Full or part-time Employment: DOTSOFT. S. Singer: Financial Interests, Personal, Other, Honoraria, outside of this study: Lilly. F. Mercalli: Financial Interests, Personal, Full or part-time Employment: Multimed Engineers Srls. L.F. Licitra: Financial Interests, Personal, Advisory Board, for expert opinion in advisory boards: AstraZeneca, Bayer, BMS, Eisai, MSD, Merck–Serono, Boehringer Ingelheim, Hoffmann-La Roche Ltd, Novartis, Roche, Debiopharm International SA, Sobi, Incyte Biosciences Italy srl, Doxa Pharma Srl, Amgen, Nanobiotics e GSK; Financial Interests, Institutional, Research Grant, Funds received by my institution for clinical studies and research activities in which I am involved: AstraZeneca, BMS, Boehringer Ingelheim, Celgene International, Eisai, Exelixis, Debiopharm International SA, Hoffmann-La Roche ltd, IRX Therapeutics, Medpace, Merck-Serono, Merck Healthcare KGaA, MSD, Novartis, Pfizer, Roche, Buran. All other authors have declared no conflicts of interest.