Iivanainen S, Baird A, Balas B, et al. Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice: protocol for an interventional, open-label, multicountry platform study (ORIGAMA), BMJ Open 2023;13:e063242. doi: https://doi.org/10.1136/bmjopen-2022-063242
Assessing the impact of digital patient monitoring on health outcomes and healthcare resource usage in addition to the feasibility of its combination with at-home treatment, in participants receiving systemic anticancer treatment in clinical practice : protocol for an interventional, open-label, multicountry platform study (ORIGAMA)
|Author:||Iivanainen, Sanna1; Baird, Anne-Marie2,3; Balas, Bogdana4;|
1Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu, Finland
2Trinity Translational Medicine Institute, Trinity College Dublin School of Medicine, Dublin, Ireland
3Lung Cancer Europe, Bern, Switzerland
4Product Development Safety, F Hoffmann-La Roche Ltd, Basel, Switzerland
5Product Development Medical Affairs, F Hoffmann-La Roche Ltd, Basel, Switzerland
6Product Development Data Sciences, F Hoffmann-La Roche Ltd, Basel, Switzerland
7Institute of Higher Education and Research in Health Care, Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland
8Department of Oncology, Lausanne University Hospital, Lausanne, Switzerland
9Product Development Global, F Hoffmann-La Roche Ltd, Basel, Switzerland
10BCLC Group, Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, Universidad de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain
11Department of Oncology, Medical Care Center, Hospital Aschaffenburg GmbH, Aschaffenburg, Germany
|Online Access:||PDF Full Text (PDF, 2.2 MB)|
|Persistent link:|| http://urn.fi/urn:nbn:fi-fe20230908122001
|Publish Date:|| 2023-09-08
Introduction: Digital patient monitoring (DPM) tools can enable more effective clinical care and improved patient outcomes in cancer. However, their broad adoption requires ease of use and demonstration of real-world clinical utility/impact. ORIGAMA (MO42720) is an interventional, open-label, multicountry platform study investigating the clinical utility of DPM tools and specific treatments. ORIGAMA will begin with two cohorts that aim to assess the impact of the atezolizumab-specific Roche DPM Module (hosted on the Kaiku Health DPM platform (Helsinki, Finland)) on health outcomes and healthcare resource usage, and its feasibility to support at-home treatment administration, in participants receiving systemic anticancer treatment. Other digital health solutions may be added to future cohorts.
Methods and analysis: In Cohort A, participants with metastatic non-small cell lung cancer (NSCLC), extensive-stage SCLC or Child Pugh A unresectable hepatocellular carcinoma will be randomised to a locally approved anticancer regimen containing intravenous atezolizumab (TECENTRIQ, F. Hoffmann-La Roche Ltd/Genentech) and local standard-of-care support, with/without the Roche DPM Module. Cohort B will assess the feasibility of the Roche DPM Module in supporting administration of three cycles of subcutaneous atezolizumab (1875 mg; Day 1 of each 21-day cycle) in the hospital, followed by 13 cycles at home by a healthcare professional (ie, flexible care), in participants with programmed cell-death ligand 1-positive, early-stage NSCLC. The primary endpoints are the mean difference in change of the participant-reported Total Symptom Interference Score at Week 12 from baseline (Cohort A) and flexible care adoption rate at Cycle 6 (Cohort B).
Ethics and dissemination: This study will be conducted according to the Declaration of Helsinki, and/or the applicable laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual. The study received its first Ethics Committee approval in Spain in October 2022. Participants will provide written informed consent in a face-to-face setting. The results of this study will be presented at national and/or international congresses and disseminated via publication in peer-reviewed journals.
Trial registration number: NCT05694013.
|Type of Publication:||
A1 Journal article – refereed
|Field of Science:||
3126 Surgery, anesthesiology, intensive care, radiology
The study will be sponsored and managed by F. Hoffmann-La Roche Ltd (grant/award number not applicable). The sponsor was involved in the conception of the study design, the writing of the report and the decision to submit the paper for publication.
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.