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Clinical Trials/NCT04613232
NCT04613232
Completed
Not Applicable

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

Rigshospitalet, Denmark1 site in 1 country10 target enrollmentJanuary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
Rigshospitalet, Denmark
Enrollment
10
Locations
1
Primary Endpoint
Number of participants who could wear the device more than 12 hours per day
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2021
End Date
December 1, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Helle Pappot

Professor, MD

Rigshospitalet, Denmark

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

Outcomes

Primary Outcomes

Number of participants who could wear the device more than 12 hours per day

Time Frame: 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 Outcomes

  • Data acquisition rate(3 months)

Study Sites (1)

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