Clinical trial NCT04613232: Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0
Official title: Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Smartwatch
Radiotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to determine the adherence to using an Apple Watch during curative intended radiotherapy for head and neck cancer. Secondly it will bring new insights to the patient's activity levels and how heart rate varies during treatment course.

Detailed description: Patients with head and neck cancer (HNC) experience severe side effects during radiotherapy (RT). Ongoing technological advances in wearable biometric sensors allow for real-time collection of objective data e.g. physical activity and heart rate, which in the future might help to detect and act against side effects before they become severe. A smartwatch such as the Apple Watch allows for objective data monitoring outside hospital with minimal effort for the patient. To find out if such tools can be implemented in the oncological setting feasibility studies are needed.

The aim of the study is to determine the adherence to using an Apple Watch during curative intended radiotherapy for head and neck cancer. Secondly it will bring new insights to the patient's activity levels and how heart rate varies during treatment course.

The study will assess the feasibility of using the Apple Watch for home monitoring of patients with HNC. It will bring new insights to the patient's activity levels and how heart rate varies during treatment course. This is important knowledge before further investigating how biometric data can be used as part of symptom monitoring.

Eligibility criteria: Inclusion Criteria:

* Danish patients ≥18 years planned to primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck at Rigshospitalet, University Hospital, Department of Oncology, Denmark.
* Able to read and speak Danish

Exclusion Criteria:

* Seious cognitive deficits

Primary outcomes:
measure: Number of participants who could wear the device more than 12 hours per day
timeFrame: 3 months
Secondary outcomes:
measure: Data acquisition rate
timeFrame: 3 months
Other outcomes:
measure: Change in heart rate
timeFrame: 3 months
measure: Change in physical activity (steps per day)
timeFrame: 3 months
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Cecilie Holländer-Mieritz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollander-Mieritz C, Vogelius IR, Kristensen CA, Green A, Rindum JL, Pappot H. Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. JMIR Res Protoc. 2021 May 13;10(5):e26096. doi: 10.2196/26096.