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

Autor: Stefano Cavalieri, Claudia Vener, Marissa LeBlanc, Laura Lopez-Perez, Giuseppe Fico, Carlo Resteghini, Dario Monzani, Giulia Marton, Gabriella Pravettoni, Mauricio Moreira-Soares, Despina Elizabeth Filippidou, Aitor Almeida, Aritz Bilbao, Hisham Mehanna, Susanne Singer, Steve Thomas, Luca Lacerenza, Alfonso Manfuso, Chiara Copelli, Franco Mercalli, Arnoldo Frigessi, Elena Martinelli, Lisa Licitra, BD4QoL Consortium, Erlend I. F. Fossen, Katherine Taylor, Paul Nankivell, Mriganke De, Ahmad Abou-Foul, Estefania Estevez-Priego, Maria Fernanda Cabrera-Umpierrez, Itziar Alonso, Sergio Copelli, Andy Ness, Miranda Pring, Katrina Hurley
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Frontiers in Oncology, Vol 13 (2023)
Druh dokumentu: article
ISSN: 2234-943X
71544941
DOI: 10.3389/fonc.2023.1048593
Popis: Patients 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).
Databáze: Directory of Open Access Journals
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