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Trial record 1 of 2 for:    apple | First posted from 11/01/2020 to 11/06/2020
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Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0 (OncoWatch)

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ClinicalTrials.gov Identifier: NCT04613232
Recruitment Status : Not yet recruiting
First Posted : November 3, 2020
Last Update Posted : February 3, 2021
Sponsor:
Information provided by (Responsible Party):
Helle Pappot, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE October 21, 2020
First Posted Date  ICMJE November 3, 2020
Last Update Posted Date February 3, 2021
Estimated Study Start Date  ICMJE March 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2020)
Data acquisition rate [ Time Frame: 3 months ]
Percentage of successful data acquisition events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 27, 2020)
  • Change in heart rate [ Time Frame: 3 months ]
    Description of change in hear rate during radiotherapy
  • Change in physical activity (steps per day) [ Time Frame: 3 months ]
    Description of change insteps per day during radiotherapy
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0
Official Title  ICMJE Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE 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)
Other Names:
  • Smartwatch
  • Apple watch
Study Arms  ICMJE Experimental: Apple Watch
The research intervention is continuously monitoring of heart rate and physical activity (minimum 12h/day) with a smartwatch which is connected to a smartphone.
Intervention: Device: Wearable sensor
Publications * Holländer-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 27, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cecilie Holländer-Mieritz, MD +45 35451454 cecilie.hollaender-mieritz@regionh.dk
Contact: Helle Pappot, Professor,MD +45 35455013 helle.pappot@regionh.dk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04613232
Other Study ID Numbers  ICMJE OncoWatch 1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helle Pappot, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cecilie Holländer-Mieritz, MD Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP