Digital tool to identify and monitor regorafenib-associated hand-foot skin reactions: A proof-of-concept study protocol.
Digital device
Metastatic colorectal cancer
Patient-reported outcomes
Regorafenib treatment
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
09
03
2023
accepted:
31
03
2023
medline:
28
7
2023
pubmed:
23
5
2023
entrez:
22
5
2023
Statut:
ppublish
Résumé
The FACET study is a prospective, open-label, low risk interventional clinical trial aiming at exploring the fitness-for-purpose and usability of an electronic device suite for the detection of hand-foot skin reaction symptoms in patients with metastatic colorectal cancer treated with regorafenib. 38 patients with metastatic colorectal cancer are being selected in 6 centers in France, and will be followed for 2 regorafenib treatment cycles, or for approximately 56 days. The electronic device suite includes connected insoles and a mobile device equipped with a camera and a companion application with electronic patient-reported outcomes questionnaires and educational material. The FACET study is intended to provide information useful for the improvement of the electronic device suite and its usability before the testing of its robustness in a larger follow-up study. This paper describes the protocol of the FACET study and discusses the limitations to consider for the implementation of digital devices in real-life practice.
Sections du résumé
BACKGROUND
The FACET study is a prospective, open-label, low risk interventional clinical trial aiming at exploring the fitness-for-purpose and usability of an electronic device suite for the detection of hand-foot skin reaction symptoms in patients with metastatic colorectal cancer treated with regorafenib.
METHODS
38 patients with metastatic colorectal cancer are being selected in 6 centers in France, and will be followed for 2 regorafenib treatment cycles, or for approximately 56 days. The electronic device suite includes connected insoles and a mobile device equipped with a camera and a companion application with electronic patient-reported outcomes questionnaires and educational material. The FACET study is intended to provide information useful for the improvement of the electronic device suite and its usability before the testing of its robustness in a larger follow-up study. This paper describes the protocol of the FACET study and discusses the limitations to consider for the implementation of digital devices in real-life practice.
Identifiants
pubmed: 37217373
pii: S1590-8658(23)00526-1
doi: 10.1016/j.dld.2023.03.013
pii:
doi:
Substances chimiques
regorafenib
24T2A1DOYB
Phenylurea Compounds
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1019-1025Informations de copyright
Copyright © 2023. Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
Conflict of interest Romain Coriat acted as consultant for Bayer, Amgen, AAA, Ipsen, Merck, BMS, Servier, Sanofi, and Novartis. Romain Coriat, Vincent Sibaud, and Mario Di Palma are members of the study Steering Committee. Michael Kremliovsky and Pierre Arvis are Bayer employees. The other authors declare no competing interests.