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Completed

NCT Number: NCT04613232

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 3450, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wearable sensor

Device

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)

Other names: Smartwatch, Apple watch

Primary outcomes

  1. 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

  1. Data acquisition rate

    Time frame: 3 months

    Percentage of successful data acquisition events

Other outcomes

  1. Change in heart rate

    Time frame: 3 months

    Description of change in hear rate during radiotherapy

  2. Change in physical activity (steps per day)

    Time frame: 3 months

    Description of change insteps per day during radiotherapy

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: OncoWatch

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 3, 2020
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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