Background: Patients with head and neck cancer (HNC) experience severe side effects during radiotherapy (RT). Ongoing technological advances in wearable biometric sensors allow for the collection of objective data (eg, physical activity and heart rate), which might, in the future, help detect and counter side effects before they become severe. A smartwatch such as the Apple Watch allows for objective data monitoring outside the hospital with minimal effort from the patient. To determine whether such tools can be implemented in the oncological setting, feasibility studies are needed.
Objective: This protocol describes the design of the OncoWatch 1.0 feasibility study that assesses the adherence of patients with HNC to an Apple Watch during RT.
Methods: A prospective, single-cohort trial will be conducted at the Department of Oncology, Rigshospitalet (Copenhagen, Denmark). Patients aged ≥18 years intended for primary or postoperative curatively intended RT for HNC will be recruited. Consenting patients will be asked to wear an Apple Watch on the wrist during and until 2 weeks after RT. The study will include 10 patients. Data on adherence, data acquisition, and biometric data will be collected. Demographic data, objective toxicity scores, and hospitalizations will be documented.
Results: The primary outcome is to determine if it is feasible for the patients to wear a smartwatch continuously (minimum 12 hours/day) during RT. Furthermore, we will explore how the heart rate and physical activity change over the treatment course.
Conclusions: The study will assess the feasibility of using the Apple Watch for home monitoring of patients with HNC. Our findings may provide novel insights into the patient's activity levels and variations in heart rate during the treatment course. The knowledge obtained from this study will be essential for further investigating how biometric data can be used as part of symptom monitoring for patients with HNC.
Trial registration: ClinicalTrials.gov NCT04613232; https://clinicaltrials.gov/ct2/show/NCT04613232.
International registered report identifier (irrid): PRR1-10.2196/26096.
Keywords: biometric sensor technology; cancer; head and neck cancer; home monitoring; patient-generated health data; radiotherapy; sensor; smartwatch.
©Cecilie Holländer-Mieritz, Ivan R Vogelius, Claus A Kristensen, Allan Green, Judith L Rindum, Helle Pappot. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.05.2021.