A multicenter randomized trial for quality of life evaluation by non-invasive intelligent tools during post-curative treatment follow-up for head and neck cancer: clinical study protocol

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dc.contributor.authorCavalieri, Stefano
dc.contributor.authorVener, Claudia
dc.contributor.authorLeBlanc, Marissa
dc.contributor.authorLopez-Perez, Laura
dc.contributor.authorFico, Giuseppe
dc.contributor.authorResteghini, Carlo
dc.contributor.authorMonzani, Dario
dc.contributor.authorMarton, Giulia
dc.contributor.authorPravettoni, Gabriella
dc.contributor.authorMoreira-Soares, Mauricio
dc.contributor.authorFilippidou, Despina Elizabeth
dc.contributor.authorAlmeida, Aitor
dc.contributor.authorBilbao Jayo, Aritz
dc.contributor.authorMehanna, Hisham
dc.contributor.authorSinger, Susanne
dc.contributor.authorThomas, Steve
dc.contributor.authorLacerenza, Luca
dc.contributor.authorManfuso, Alfonso
dc.contributor.authorCopelli, Chiara
dc.contributor.authorMercalli, Franco
dc.contributor.authorFrigessi, Arnoldo
dc.contributor.authorMartinelli, Elena
dc.contributor.authorLicitra, Lisa
dc.contributor.authorEstevez-Priego, Estefania
dc.date.accessioned2025-07-08T10:16:12Z
dc.date.available2025-07-08T10:16:12Z
dc.date.issued2023-01-31
dc.date.updated2025-07-08T10:16:12Z
dc.description.abstractPatients surviving head and neck cancer (HNC) suffer from high physical, psychological, and socioeconomic burdens. Achieving cancer-free survival with an optimal quality of life (QoL) is the primary goal for HNC patient management. So, maintaining lifelong surveillance is critical. An ambitious goal would be to carry this out through the advanced analysis of environmental, emotional, and behavioral data unobtrusively collected from mobile devices. The aim of this clinical trial is to reduce, with non-invasive tools (i.e., patients’ mobile devices), the proportion of HNC survivors (i.e., having completed their curative treatment from 3 months to 10 years) experiencing a clinically relevant reduction in QoL during follow-up. The Big Data for Quality of Life (BD4QoL) study is an international, multicenter, randomized (2:1), open-label trial. The primary endpoint is a clinically relevant global health-related EORTC QLQ-C30 QoL deterioration (decrease ≥10 points) at any point during 24 months post-treatment follow-up. The target sample size is 420 patients. 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 patients monitoring and empowerment through two main tools: a mobile application installed on participants’ smartphones, that includes a chatbot for e-coaching, and the Point of Care dashboard, to let the investigators manage patients data. In both arms, participants will be asked to complete QoL questionnaires at study entry and once every 6 months, and will undergo post-treatment follow up as per clinical practice. Patients randomized to the intervention arm (n=280) will receive access to the BD4QoL platform, those in the control arm (n=140) will not. Eligibility criteria include completing curative treatments for non-metastatic HNC and the use of an Android-based smartphone. Patients undergoing active treatments or with synchronous cancers are excluded. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT05315570).en
dc.description.sponsorshipThe study is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (INT), Italy. The BD4QoL project, in the frame of which this work is being conducted, has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 875192en
dc.identifier.citationCavalieri, S., Vener, C., LeBlanc, M., Lopez-Perez, L., Fico, G., Resteghini, C., Monzani, D., Marton, G., Pravettoni, G., Moreira-Soares, M., Filippidou, D. E., Almeida, A., Bilbao, A., Mehanna, H., Singer, S., Thomas, S., Lacerenza, L., Manfuso, A., Copelli, C., et al. (2023). A multicenter randomized trial for quality of life evaluation by non-invasive intelligent tools during post-curative treatment follow-up for head and neck cancer: clinical study protocol. Frontiers in Oncology, 13. https://doi.org/10.3389/FONC.2023.1048593
dc.identifier.doi10.3389/FONC.2023.1048593
dc.identifier.eissn2234-943X
dc.identifier.urihttps://hdl.handle.net/20.500.14454/3167
dc.language.isoeng
dc.publisherFrontiers Media S.A.
dc.rights© 2023 Cavalieri, Vener, LeBlanc, LopezPerez, Fico, Resteghini, Monzani, Marton, Pravettoni, Moreira-Soares, Filippidou, Almeida, Bilbao, Mehanna, Singer, Thomas, Lacerenza, Manfuso, Copelli, Mercalli, Frigessi, Martinelli, Licitra and BD4QoL Consortium
dc.subject.otherAndroid
dc.subject.otherBD4QoL
dc.subject.otherHead and neck cancer
dc.subject.otherMHealth
dc.subject.otherQOL
dc.subject.otherSurvivorship
dc.subject.otherUnobtrusive
dc.titleA multicenter randomized trial for quality of life evaluation by non-invasive intelligent tools during post-curative treatment follow-up for head and neck cancer: clinical study protocolen
dc.typejournal article
dcterms.accessRightsopen access
oaire.citation.titleFrontiers in Oncology
oaire.citation.volume13
oaire.licenseConditionhttps://creativecommons.org/licenses/by/4.0/
oaire.versionVoR
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