Introduction Mobile health technologies may enhance patient empowerment and data integration along the whole care continuum. However, these interventions pose relatively new regulatory, organisational and technological challenges that limit appropriate evaluation. Lung Cancer App (LuCApp) is a mobile application developed by researchers and clinicians to promote real-time monitoring and management of patients’ symptoms. This protocol illustrates a clinical trial designed to evaluate the usability, effectiveness and cost-effectiveness of LuCApp versus standard of care.
Methods and analysis This is a 24-week two-arm non-blinded multicentre parallel randomised controlled trial. A total of 120 adult patients diagnosed with small or non-small cell lung cancer and eligible for pharmaceutical treatments will be allocated 1:1 to receiving either standard care or LuCApp in addition to standard care at three oncology sites in Northern Italy. During the treatment period, LuCApp allows daily monitoring and grading of a list of symptoms, which trigger alerts to the physicians in case predefined severity thresholds are met. Patients will complete a baseline assessment and a set of valid and reliable patient-reported outcome measures every 3±1 weeks, and up to 24 weeks. The primary outcome is the change in the score of the Trial Outcome Index in the Functional Assessment of Cancer Therapy (Lung) questionnaire from baseline to 12 weeks. Secondary outcomes are the Lung Cancer Subscale, the EuroQoL 5D-5L questionnaire, the Hospital Anxiety and Depression Scale, the Supportive Care Needs Survey Short Form, the app usability questionnaire and the Zarit Burden Interview for the main caregiver.
Ethics and dissemination The trial received ethical approval from the three clinical sites. Trial results will be disseminated through peer-reviewed publications and conference presentations.
Conclusions This trial makes a timely contribution to test a mobile application designed to improve the quality of life and delivery of care for patients with lung cancer.
Trial registration number NCT03512015; Pre-results.
- lung cancer
- health-related quality of life
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Patient consent for publication Not required.
Contributors MC and RT developed the initial trial concept. OC, MC and FP devised the study design, drafted the protocol and contributed to critical revisions of the manuscript. RT is the Chief Investigator and takes overall responsibility for all aspects of trial design, the protocol and the trial conduct. GA, GM, SN, PP, NZ, CB, EC, MG, EN contributed to revisions of the protocol and have read and approved this manuscript.
Funding This research was promoted by SDA Bocconi School of Management.
Competing interests OC, MC, FP, RT report grant from Helsinn Healthcare SA, during the conduct of the study; and are currently involved in the COMED H2020 EU project nr 779306. GA, NZ, MG report grant from Università Bocconi, during the conduct of the study. EN reports grants from Horizon2020 funding from the European Commission for IMPACT HTA project, personal fees from Dolon Consultancy, personal fees from previous consultancy and teaching activities, outside the submitted work. SN reports personal fees as speaker bureau from BMS, MSD, Takeda, BI, Roche, AstraZeneca, Eli Lillly, outside the submitted work.
Ethics approval The trial received ethical approval from the ethics committees at the three clinical sites: Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Fondazione IRCCS Istituto Nazionale dei Tumori and Azienda Ospedaliero-Universitaria San Luigi Gonzaga.
Provenance and peer review Not commissioned; externally peer reviewed.