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NCT04613232 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— OncoWatch  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04613232
Other study ID # OncoWatch 1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 22, 2021
Est. completion date December 1, 2021

Study information
Verified date September 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 1, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Wearable sensor
The patients will be asked to wear an Apple Watch during their treatment course. The watch will pasively collect sensor data (heart rate and physical activity)

Locations
Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Change in heart rate Description of change in hear rate during radiotherapy 3 months
Other Change in physical activity (steps per day) Description of change insteps per day during radiotherapy 3 months
Primary Number of participants who could wear the device more than 12 hours per day 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 3 months
Secondary Data acquisition rate Percentage of successful data acquisition events 3 months
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