Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0

Not Applicable

Completed

• Conditions: Head and Neck Cancer
• Interventions: Device: Wearable sensor

• Registration Number: NCT04613232
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-03
• Study Start: 2021-01-22
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-01
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apple Watch	Wearable sensor	The research intervention is continuously monitoring of heart rate and physical activity (minimum 12h/day) with a smartwatch which is connected to a smartphone.

Primary Outcome Measures

Name	Time	Method
Number of participants who could wear the device more than 12 hours per day	3 months	To determine the feasibility of using an Apple Watch to obtain biometric data for patients undergoing head and neck locoregional therapy throughout the duration of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Data acquisition rate	3 months	Percentage of successful data acquisition events

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark