Development of the GIMEMA-ALLIANCE Digital Health Platform for Patients with Hematologic Malignancies in the COVID-19 Pandemic and Post-Pandemic Era: A Study Protocol

• Published in: JMIR research protocols 2021-04
• Main Authors: Efficace, Fabio, Breccia, Massimo, Fazi, Paola, Cottone, Francesco, Holzner, Bernhard, Vignetti, Marco
• Format: Article
• Language: English
• ISSN: 1929-0748; 1929-0748

The COVID-19 pandemic has raised unprecedented challenges in the management of cancer patients and has increased the demands for digital health tools that, for example, could facilitate remote monitoring of patients. On this ground, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) has recently developed a digital health tool dedicated to patients with hematologic malignancies: the GIMEMA-ALLIANCE platform. The main objectives of this web-based platform are: to generate relevant data to better understand quality of life, symptoms and medication adherence during the COVID-19 pandemic and post-pandemic era; to develop a prospective real-life registry on outcomes of hematologic cancer patients, with or without a diagnosis of COVID-19; to facilitate patient-centered care in routine practice. The platform consists of a physician- and a patient-secure portal and enables electronic patient-reported outcome (ePRO) assessments with real-time graphical presentation (to physicians) of individual patient symptoms and quality of life outcomes. Automated alerts are sent to treating hematologists based on the following predetermined criteria: presence of clinically important problems and symptoms; problems with adherence to therapy; risk of COVID-19 diagnosis. The platform also allows physicians to set up video consultations. Clinical information on disease and treatment, as well as clinical and survival outcomes are also prospectively collected. Use of this platform may help to improve patient-physician communication and facilitate hematologists in the early recognition of clinically important problems and symptoms of their patients. More than 25 community and university-based hospitals have currently agreed to participate. In addition to PRO data, the prospective collection of disease and treatment related information, as well as data on possible COVID-19 diagnosis and COVID-19 vaccination, will allow to develop a large database to also identify subgroup of patients at risk of poor outcomes. We expect that data generated via this platform will help to answer clinically relevant questions for patients with hematologic malignancies during the COVID-19 pandemic and post-pandemic era. We also expect that use of the GIMEMA-ALLIANCE platform in routine clinical practice, will improve patient-centered care delivery. ClinicalTrials.gov NCT04581187.