Usability Testing of a New Digital Integrated Health Ecosystem (PainRELife) for the Clinical Management of Chronic Pain in Patients With Early Breast Cancer: Protocol for a Pilot Study
Authors: Masiero Marianna , Filipponi Chiara , Pizzoli Silvia Francesca Maria , Munzone Elisabetta , Guido Luca , Guardamagna Vittorio Andrea , Marceglia Sara , Caruso Annamaria , Prandin Roberto , Prenassi Marco , Manzelli Vania , Savino Chiara , Conti Costanza , Rizzi Federica , Casalino Alice , Candiani Giulia , Memini Francesca , Chiveri Luca , Vitali Andrea Luigi , Corbo Massimo , Milani Alessandra , Grasso Roberto , Traversoni Silvia , Fragale Elisa , Didier Florence , Pravettoni Gabriella 
Published: March 2023

Background
Chronic pain (CP) and its management are critical issues in the care pathway of patients with breast cancer. Considering the complexity of CP experience in cancer, the international scientific community has advocated identifying cutting-edge approaches for CP management. Recent advances in the field of health technology enable the adoption of a novel approach to care management by developing integrated ecosystems and mobile health apps.

Objective
The primary end point of this pilot study is to evaluate patients’ usability experience at 3 months of a new digital and integrated technological ecosystem, PainRELife, for CP in a sample of patients with breast cancer. The PainRELife ecosystem is composed of 3 main technological assets integrated into a single digital ecosystem: Fast Healthcare Interoperability Resources–based cloud platform (Nu platform) that enables care pathway definition and data collection; a big data infrastructure connected to the Fast Healthcare Interoperability Resources server that analyzes data and implements dynamic dashboards for aggregate data visualization; and an ecosystem of personalized applications for patient-reported outcomes collection, digital delivery of interventions and tailored information, and decision support of patients and caregivers (PainRELife app).

Methods
This is an observational, prospective pilot study. Twenty patients with early breast cancer and chronic pain will be enrolled at the European Institute of Oncology at the Division of Medical Senology and the Division of Pain Therapy and Palliative Care. Each patient will use the PainRELife mobile app for 3 months, during which data extracted from the questionnaires will be sent to the Nu Platform that health care professionals will manage. This pilot study is nested in a large-scale project named “PainRELife,” which aims to develop a cloud technology platform to interoperate with institutional systems and patients' devices to collect integrated health care data. The study received approval from the Ethical Committee of the European Cancer Institute in December 2021 (number R1597/21-IEO 1701).

Results
The recruitment process started in May 2022 and ended in October 2022.

Conclusions
The new integrated technological ecosystems might be considered an encouraging affordance to enhance a patient-centered approach to managing patients with cancer. This pilot study will inform about which features the health technological ecosystems should have to be used by cancer patients to manage CP.

International Registered Report Identifier (IRRID)
DERR1-10.2196/41216