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da Silva Lopes AM, Colomer-Lahiguera S, Darnac C, Giacomini S, Bugeia S, Gutknecht G, Spurrier-Bernard G, Cuendet MA, Muet F, Aedo-Lopez V, Mederos Alfonso NN, Michielin O, Addeo A, Latifyan S, Eicher M
Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial
Testing a model of care for patients on immune-checkpoint inhibitors based on electronic patient-reported outcomes: Protocol for a randomized phase II controlled trial
André Manuel da Silva Lopes;
Sara Colomer-Lahiguera;
Célia Darnac;
Stellio Giacomini;
Sébastien Bugeia;
Garance Gutknecht;
Gilliosa Spurrier-Bernard;
Michel Alain Cuendet;
Fanny Muet;
Veronica Aedo-Lopez;
Nuria Neisy Mederos Alfonso;
Olivier Michielin;
Alfredo Addeo;
Sofiya Latifyan;
Manuela Eicher
ABSTRACT
Background:
Management of severe symptomatic immune-related adverse events (IrAEs) related to immune-checkpoint inhibitors (ICI) can be facilitated by timely detection of these complications. As patients face a heterogeneous set of symptoms outside the clinical setting, remotely monitoring and assessing symptoms using patient-reported outcomes (PRO) may result in shorter delays between symptom onset and clinician detection.
Objective:
This study is designed to assess the effect of a model of care based on PRO data on the time to detection of symptomatic IrAEs from symptom onset.
Methods:
198 patients with cancer receiving systemic treatment comprised exclusively of ICI will be recruited from two Swiss university hospitals. Patients are randomized (1:1) to a digital model of care (intervention) or usual care (control group). Patients are enrolled for six months and use an electronic application to complete questionnaires. Patients in the intervention group complete a weekly PRO-CTCAE™ questionnaire and reassess active symptoms daily for the first three months. Nurses call patients in the event of new or worsening symptoms and manage them, using a standardized triage algorithm. Outcomes of interest include time to IrAE detection (primary outcome), time to IrAE intervention, IrAE grade (severity), health-related quality of life, self-efficacy and overall survival.
Results:
This study has received funding from the ISREC foundation and Kaiku Health Ltd. It is in active recruitment since November 2021 and is projected to conclude in November 2023. Trial results will be disseminated through publications in scientific journals, abstracts and presentations submitted at international scientific conferences.
Conclusions:
This trial is among the first trials to use PRO data to directly influence routine care of patient treated with ICI. It aims to demonstrate the challenges of diagnosing and managing symptoms associated with treatment remotely, providing further insight into the burden they represent to patients on a daily basis. Clinical Trial: ClinicalTrials.gov Identifier : NCT05530187
Citation
Please cite as:
da Silva Lopes AM, Colomer-Lahiguera S, Darnac C, Giacomini S, Bugeia S, Gutknecht G, Spurrier-Bernard G, Cuendet MA, Muet F, Aedo-Lopez V, Mederos Alfonso NN, Michielin O, Addeo A, Latifyan S, Eicher M
Testing a Model of Care for Patients on Immune Checkpoint Inhibitors Based on Electronic Patient-Reported Outcomes: Protocol for a Randomized Phase II Controlled Trial