Digital tool to identify and monitor regorafenib-associated hand-foot skin reactions: A proof-of-concept study protocol.

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.