Designing and conducting interventional trials with passive-sensing applications on patient-owned smartphones: challenges and recommendations from the BD4QoL study

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The BD4QoL study utilized a digital platform on smartphones to monitor quality of life in head and neck cancer survivors.
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Challenges in the trial included device heterogeneity, reliance on third-party apps, and regulatory concerns.
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Digital health interventions require rigorous evaluation to demonstrate efficacy, safety, and usability comparable to traditional treatments.
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The study highlights the need for well-designed interventional studies to address operational complexities in digital health research.
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Insights from the trial can inform policy makers and promote best practices in the implementation of digital health technologies.

Frontiers In Digital Health

by Francesco Giuliani, Laura Lopez-Perez, Franco Mercalli, Tessa Fulton-Lieuw, Claudia Vener, Francesco Ricciardi, Michela Falcone, Antonio Mangiacotti, Stefano Cavalieri, Antonello Manocchio, Elena Martinelli, Luca Maria Lacerenza, Chiara Copelli, Despina Elizabeth Filippidou, Aritz Bilbao, Aitor Almeida, Hisham Mehanna, Giuseppe Fico, Lisa Licitra
July 13, 2026

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