Designing and conducting interventional trials with passive-sensing applications on patient-owned smartphones: challenges and recommendations from the BD4QoL study - Report - 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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Clinical Report: Conducting Interventional Trials Utilizing Passive-Sensing Technologies

Overview

The BD4QoL study identifies challenges such as device heterogeneity, reliance on third-party apps, and regulatory concerns in conducting interventional trials using passive-sensing technologies on personal smartphones in head and neck cancer survivors.

Background

Digital health technologies are transforming healthcare delivery, particularly in oncology, by enabling continuous monitoring of patient outcomes. Head and neck cancer survivors face significant long-term impairments, which necessitate careful evaluation of these technologies in clinical trials due to unique methodological and operational challenges.

Data Highlights

No numerical data was provided in the source material.

Key Findings

  • Device heterogeneity and reliance on third-party applications were significant challenges.
  • Regulatory concerns and methodological barriers were encountered during trial execution.
  • Patient recruitment and adherence issues were noted.
  • Technical reliability and data integration into clinical workflows posed challenges.
  • Insights from trials can inform policy and regulatory pathways for digital health interventions.

Clinical Implications

The challenges of implementing digital health interventions were identified, which may inform future clinical trial designs.

Conclusion

The BD4QoL study provides insights into the complexities of conducting interventional trials with digital health technologies.

Related Resources & Content

  1. npj Digital Medicine, 2025 -- Active remote monitoring of long-term conditions with mobile devices: a systematic review of cost-effectiveness analyses
  2. Frontiers in Pain Research, 2026 -- Exploring the predictive capacity of smartphone-based digital phenotyping to monitor pain and physical quality of life in advanced cancer patients, family caregivers, and dyads
  3. Clinical Research in Cardiology, 2020 -- Impact of Remote Monitoring on Anxiety, Depression, Quality of Life, and Device Acceptance in Patients with Implantable Cardioverter-Defibrillators: A Prospective, Randomized, Controlled Single-Center Study
  4. E6(R3) Good Clinical Practice (GCP) | FDA
  5. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | FDA
  6. NCCN Guidelines® Insights: Survivorship, Version 2.2025 - PubMed
  7. Hernia — Utilizing a Mobile Application to Detect Postoperative Complications Following Inguinal Hernia Surgery: A Comparative Cohort Analysis
  8. Time to shift supportive care toward digital-assisted approaches?
  9. Evaluating Effectiveness of mHealth Interventions for Rehabilitation in Patients With Head and Neck Cancer: Systematic Review and Meta-Analysis of Randomized Controlled Trials
  10. E6(R3) Good Clinical Practice (GCP) | FDA
  11. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations | FDA
  12. NCCN Guidelines® Insights: Survivorship, Version 2.2025 - PubMed

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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