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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program

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Obtaining Patient-Reported Outcome Data via a Home Patient Monitoring App: Development, Implementation, and

Lucia Sacchi¹, Giordano Lanzola¹, Silvana Quaglini¹

¹Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Via Ferrata 5, Pavia, 27100, Italy, +39 0382 985218.

JMIR Mhealth and Uhealth

|December 11, 2025

Summary

A new patient-friendly terminology for cancer treatment adverse events (AEs) was developed and validated. This system improves AE reporting for better clinical decision support and patient care.

Keywords:

patient-reported adverse effects cancer clinical decision support system decision-making home patient mHealth mobile app patient with cancer patient-reported outcome quality of life self-reporting symptom assessment

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Area of Science:

Oncology
Health Informatics
Patient-Reported Outcomes

Background:

Adverse events (AEs) from cancer treatment are crucial for therapy adjustment.
Current Common Terminology Criteria for Adverse Events (CTCAE) is challenging for patient self-reporting via mobile health technologies.
Existing patient-oriented companions lack completeness and precision for continuous monitoring.

Purpose of the Study:

To propose a novel AE reporting terminology that is user-friendly for patients.
To ensure clinical meaningfulness for healthcare providers and exploitability for decision support systems.
To implement and validate this new terminology within the CAPABLE EU project.

Main Methods:

Adapted and reduced the CTCAE list through a participatory approach with patients and providers.
Integrated the new terminology into a mobile app for the CAPABLE project.
Conducted a clinical pilot study with 86 patients monitored via the app and a control group of 133 patients.

Main Results:

The final terminology includes 124 AEs, with 49 binary and 77 graded by severity.
The pilot study showed high patient engagement in symptom reporting, including 24 AEs not in Patient-Reported Outcomes-CTCAE.
The terminology enabled the CAPABLE decision support tool to trigger 11 clinical recommendations.

Conclusions:

A novel AE self-reporting terminology is needed, offering ease of use, completeness, and clinical relevance.
Mapping the new terminology to CTCAE allows for the use of self-reported data to activate decision support rules.
This approach aligns with clinical practice guidelines and enhances patient monitoring.