Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Jul 22;31(8):484.
doi: 10.1007/s00520-023-07934-w.

Development of an eHealth-enhanced model of care for the monitoring and management of immune-related adverse events in patients treated with immune checkpoint inhibitors

Affiliations
Clinical Trial

Development of an eHealth-enhanced model of care for the monitoring and management of immune-related adverse events in patients treated with immune checkpoint inhibitors

André Manuel da Silva Lopes et al. Support Care Cancer. .

Abstract

Purpose: The use of electronic patient-reported outcome (ePRO) data in routine care has been tied to direct patient benefits such as improved quality of care and symptom control and even overall survival. The modes of action behind such benefits are seldom described in detail. Here, we describe the development of a model of care leveraging ePRO data to monitor and manage symptoms of patients treated with immune checkpoint inhibitors.

Methods: Development was split into four stages: (1) identification of an underlying theoretical framework, (2) the selection of an ePRO measure (ePROM), (3) the adaptation of an electronic application to collect ePRO data, and (4) the description of an ePRO-oriented workflow. The model of care is currently evaluated in a bicentric longitudinal randomized controlled phase II trial, the IePRO study.

Results: The IePRO model of care is grounded in the eHealth Enhanced Chronic Care Model. Patients are prompted to report symptoms using an electronic mobile application. Triage nurses are alerted, review the reported symptoms, and contact patients in case of a new or worsening symptom. Nurses use the UKONS 24-hour telephone triage tool to issue patient management recommendations to the oncology team. Adapted care coordinating procedures facilitate team collaboration and provide patients with timely feedback.

Conclusion: This report clarifies how components of care are created and modified to leverage ePRO to enhance care. The model describes a workflow that enables care teams to be proactive and provide patients with timely, multidisciplinary support to manage symptoms.

Keywords: Immune-related adverse events; Model of care; Patient-reported outcomes; Remote symptom management; Self-management support.

PubMed Disclaimer

Conflict of interest statement

A.D.S.L., C.D., S.G., S.B., G.G., V.A.L., N.M.A., S.L., and A. A. have no relevant financial or non-financial interests to disclose. S.C.L. reports grants from the ISREC Foundation. G.S-B. reports grants from MSD France, grants from Novartis, and personal fees from Bayer, MPNE, and WECAN, outside the submitted work. O.M. reports grants and personal fees from BMS, MSD, Pierre-Fabre, and Amgem; personal fees from Roche, Novartis, and GSL; and grants from Merck, outside the submitted work. M.E. received institutional research grants from Kaiku Health and reports grants from Bristol Myers Squibb, Roche and institutional fees as a Scientific Advisory Board Member/Consultant from Roche, outside the submitted work.

Figures

Fig. 1
Fig. 1
The eHealth Enhanced Chronic Care Model (eCCM), adapted from: Gee PM, Greenwood DA, Paterniti DA, Ward D, Miller LMS. The eHealth Enhanced Chronic Care Model: A Theory Derivation Approach. Journal of Medical Internet Research 2015;17:e86. 10.2196/jmir.4067. The original is licensed under a Creative Commons Attribution license (CC-BY)
Fig. 2
Fig. 2
ePRO application—questionnaire interface (left) and patient feedback view (right)
Fig. 3
Fig. 3
Overview of the IePRO model of care: patients perform self-assessment (1) and declare potential symptoms using the symptom ePROM in the electronic application (2). Telephone triage nurses review PRO data and coordinate with the oncology team preemptively when necessary (3) and contact patients by telephone using a standardized triage process (4)
Fig. 4
Fig. 4
ePRO app—triage nurse’s view

Similar articles

Cited by

References

    1. Vaddepally RK, Kharel P, Pandey R, Garje R, Chandra AB. Review of indications of FDA-approved immune checkpoint inhibitors per NCCN guidelines with the level of evidence. Cancers. 2020;12:738. doi: 10.3390/cancers12030738. - DOI - PMC - PubMed
    1. Schneider BJ, Naidoo J, Santomasso BD, Lacchetti C, Adkins S, Anadkat M, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO guideline update. J Clin Oncol. 2021;39:4073–4126. doi: 10.1200/JCO.21.01440. - DOI - PubMed
    1. Ramos-Casals M, Brahmer JR, Callahan MK, Flores-Chávez A, Keegan N, Khamashta MA, et al. Immune-related adverse events of checkpoint inhibitors. Nat Rev Dis Primer. 2020;6:38. doi: 10.1038/s41572-020-0160-6. - DOI - PMC - PubMed
    1. Haanen JBAG, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 2017;28:iv119–42. 10.1093/annonc/mdx225 - PubMed
    1. Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob J-J, Cowey CL, et al. Overall survival with combined nivolumab and ipilimumab in advanced melanoma. N Engl J Med. 2017;377:1345–1356. doi: 10.1056/NEJMoa1709684. - DOI - PMC - PubMed

Publication types

Substances