1Head and Neck Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere
Scientifico Istituto Nazionale dei Tumori, Milan, Italy
2Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy
3Oslo Center for Biostatistics and Epidemiology, University of Oslo, Oslo, Norway
4Oslo Center for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway
5Universidad Politécnica de Madrid-Life Supporting Technologies Research Group, ETSIT, Madrid, Spain
6Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology
IRCCS, Milan, Italy
7Department of Psychology, Educational Science and Human Movement (SPPEFF), University of
Palermo, Palermo, Italy
8Information Technology Programme Management Office, DOTSOFT, Thessaloniki, Greece
9DeustoTech, Faculty of Engineering, Universidad de Deusto, Bilbao, Spain
10Institute of head and neck studies and Education, University of Birmingham, Birmingham, United
Kingdom
11Division of Epidemiology and Health Care Research, JGU – Johannes Gutenberg University, Mainz,
Germany
Scientific Results / Publications 19 | P a g e
12Division of Oral and Maxillofacial Surgery – Bristol Dental Hospital, University of Bristol – Bristol
Medical School, Bristol, United Kingdom
13Maxillo-Facial Surgery, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy
14Maxillo-Facial Surgery, Interdisciplinary Department of Medicine, University of Bari “Aldo Moro”, Bari,
Italy
15MultiMed Engineers srls, Parma, Italy
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 followup. 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.