The GIMEMA-ALLIANCE Digital Health Platform for Patients With Hematologic Malignancies in the COVID-19 Pandemic and Postpandemic Era: Protocol for a Multicenter, Prospective, Observational Study

Fabio Efficace, Massimo Breccia, Paola Fazi, Francesco Cottone, Bernhard Holzner, Marco Vignetti, Fabio Efficace, Massimo Breccia, Paola Fazi, Francesco Cottone, Bernhard Holzner, Marco Vignetti

Abstract

Background: The COVID-19 pandemic has raised unprecedented challenges in the management of patients with cancer and has increased the demands for digital health tools that, for example, could facilitate remote monitoring of patients. Based on this, 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.

Objective: 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 postpandemic era; to develop a prospective real-life registry on outcomes of patients with hematologic cancer, with or without a diagnosis of COVID-19; and to facilitate patient-centered care in routine practice.

Methods: The platform consists of physician- and patient-secure portals 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, and risk of COVID-19 diagnosis. The platform also allows physicians to set up video consultations. Clinical information regarding disease and treatment as well as clinical and survival outcomes are also prospectively collected.

Results: Recruitment of participants started in December 2020. As of April 2021, a total of 116 patients have been enrolled in this study. Use of this platform may help to improve patient-physician communication and help hematologists in the early recognition of clinically important problems and symptoms of their patients. More than 20 community and university-based hospitals have currently agreed to participate. In addition to patient-reported outcome 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 the development of a large database to also identify subgroups of patients at risk of poor outcomes.

Conclusions: Data generated via this platform will help to answer clinically relevant questions for patients with hematologic malignancies during the COVID-19 pandemic and postpandemic era. The use of the GIMEMA-ALLIANCE platform in routine practice may also contribute to enhancing patient-centered care.

Trial registration: ClinicalTrials.gov NCT04581187; https://ichgcp.net/clinical-trials-registry/NCT04581187.

International registered report identifier (irrid): PRR1-10.2196/25271.

Keywords: COVID-19; digital health; hematology; leukemia; lymphoma; multiple myeloma; patient-reported outcomes; quality of life; symptoms.

Conflict of interest statement

Conflicts of Interest: BH holds intellectual property rights on the CHES software tool.

©Fabio Efficace, Massimo Breccia, Paola Fazi, Francesco Cottone, Bernhard Holzner, Marco Vignetti. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 01.06.2021.

Figures

Figure 1
Figure 1
Main workflow of the GIMEMA-ALLIANCE platform. ALLIANCE: An online platform to improve patient-centered care during the COVID-19 pandemic: A GIMEMA surveillance program in hematologic malignancies; CHES: Computer-based Health Evaluation System; GIMEMA: Gruppo Italiano Malattie Ematologiche dell’Adulto.
Figure 2
Figure 2
GIMEMA-ALLIANCE patient portal. ALLIANCE: An online platform to improve patient-centered care during the COVID-19 pandemic: A GIMEMA surveillance program in hematologic malignancies; GIMEMA: Gruppo Italiano Malattie Ematologiche dell’Adulto.
Figure 3
Figure 3
EORTC QLQ-C30 thresholds for clinical importance (TCIs). TCIs are shown inside the bars. Patient scores in the orange range of the bar (ie, below the TCI for functioning scales or above the TCI for symptom scales) indicate clinically important problems or symptoms. Reprinted from Giesinger et al (2020) [35]). EORTC: European Organisation for Research and Treatment of Cancer; QLQ-C30: Quality of Life Questionnaire–Core.
Figure 4
Figure 4
Example of graphical display of results of patient-reported symptoms available on the physician portal. The red vertical bar indicates a clinically important symptom.
Figure 5
Figure 5
Schematic workflow of the patient-generated alerts to the medical team. ALLIANCE: An online platform to improve patient-centered care during the COVID-19 pandemic: A GIMEMA surveillance program in hematologic malignancies; PRO: patient-reported outcome.

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