Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study.
biometric sensor technology
cancer
head and neck cancer
home monitoring
patient-generated health data
radiotherapy
sensor
smartwatch
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
13 May 2021
13 May 2021
Historique:
received:
01
12
2020
accepted:
12
04
2021
revised:
03
03
2021
entrez:
13
5
2021
pubmed:
14
5
2021
medline:
14
5
2021
Statut:
epublish
Résumé
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. 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. 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. 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. 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. ClinicalTrials.gov NCT04613232; https://clinicaltrials.gov/ct2/show/NCT04613232. PRR1-10.2196/26096.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT04613232; https://clinicaltrials.gov/ct2/show/NCT04613232.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
PRR1-10.2196/26096.
Identifiants
pubmed: 33983123
pii: v10i5e26096
doi: 10.2196/26096
pmc: PMC8160816
doi:
Banques de données
ClinicalTrials.gov
['NCT04613232']
Types de publication
Journal Article
Langues
eng
Pagination
e26096Informations de copyright
©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.
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