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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: Wearable sensor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Monitoring Patients During Radiotherapy Using Biometric Sensor Data: the OncoWatch Study 1.0
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Data acquisition rate [ Time Frame: 3 months ]
    Percentage of successful data acquisition events


Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613232


Contacts
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Contact: Cecilie Holländer-Mieritz, MD +45 35451454 cecilie.hollaender-mieritz@regionh.dk
Contact: Helle Pappot, Professor,MD +45 35455013 helle.pappot@regionh.dk

Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Cecilie Holländer-Mieritz, MD Rigshospitalet, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helle Pappot, Professor, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04613232    
Other Study ID Numbers: OncoWatch 1.0
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helle Pappot, Rigshospitalet, Denmark:
Smartwatch
Radiotherapy
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms