A technological architecture for the clinical management of chronic pain in early breast cancer pa-tients: The PainRELife study protocol (Preprint)

BACKGROUND Recent advances in the field of information and communication technology enable the adoption of a novel and challenging approach to care management in the oncological domain by developing integrated ecosystems and health mobile applications. OBJECTIVE The primary endpoint of this pilot study is to evaluate patients’ usability experience at 3-months of a new digital and integrated technological ecosystem (composed of a platform in which patient health data are stored and its mobile application for care monitoring and momentary ecological assessments) for chronic pain in a sample of breast cancer patients. METHODS This is an observational, prospective pilot study. Twenty patients with early breast cancer and chronic pain will be enrolled. Each patient will use the PainRELife mobile application for 3 months, during which data extracted from the questionnaires will be sent to the Nu Platform that healthcare professionals will manage. This pilot study is nested in a large-scale project named “PainRELife" which aims to develop a cloud technology platform able to inter-operate with institutional systems and patients' devices to collect integrated healthcare data. The study received approval from the Ethical Committee of the European Cancer Institute in December 2021 (n. R1597/21-IEO 1701). RESULTS The study is recruiting, and data collection is expected to be completed in September 2022. CONCLUSIONS The new integrated technological ecosystems might be considered an encouraging affordance to enhance a patient-centered approach to managing cancer patients. This pilot study will inform about which features the health technological ecosystems should have to be used by cancer patients to manage chronic pain.