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

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

  • 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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Objective:

To report key lessons from the BD4QoL multicenter randomized clinical trial (RCT) regarding the implementation of a digital platform for monitoring quality of life in head and neck cancer survivors.

Approach:
  • Trial Execution Challenges: The paper describes challenges encountered during trial execution, including device heterogeneity, reliance on third-party apps, regulatory concerns, and methodological barriers.
  • BYOD Deployment: It examines the challenges of conducting a multicenter randomized trial based on passive sensing and a Bring Your Own Device (BYOD) approach.
Key Findings:
  • Digital health technologies can support cancer survivorship but introduce methodological and operational complexities.
  • Issues such as patient recruitment, adherence, technical reliability, and data integration into clinical workflows frequently emerge.
  • Existing literature highlights barriers in using patient-owned mobile technologies for remote monitoring.
Interpretation:

Limitations:
  • Variability in patients' ability to engage with digital technologies.
  • Possible exclusion of patients using specific smartphone devices or operating systems.
  • Limitations in continuity of data collection and standardization.
Conclusion:

The study emphasizes the need for rigorous investigation and validation of digital health interventions in oncology.

Original Source(s)

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

  • 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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