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

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Wearable sensor

About this trial

This is an interventional supportive care trial for Head and Neck Cancer focused on measuring Smartwatch, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apple Watch

Arm Description

The research intervention is continuously monitoring of heart rate and physical activity (minimum 12h/day) with a smartwatch which is connected to a smartphone.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Data acquisition rate

Percentage of successful data acquisition events

Full Information

NCT ID

NCT04613232

First Posted

October 21, 2020

Last Updated

September 1, 2022

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT04613232

Brief Title

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

Acronym

OncoWatch

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

January 22, 2021 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

Smartwatch, Radiotherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Apple Watch

Arm Type

Experimental

Arm Description

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 Type

Device

Intervention Name(s)

Wearable sensor

Other Intervention Name(s)

Smartwatch, Apple watch

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Data acquisition rate

Description

Percentage of successful data acquisition events

Time Frame

3 months

Other Pre-specified Outcome Measures:

Title

Change in heart rate

Description

Description of change in hear rate during radiotherapy

Time Frame

3 months

Title

Change in physical activity (steps per day)

Description

Description of change insteps per day during radiotherapy

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cecilie Holländer-Mieritz, MD

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

ZIP/Postal Code

3450

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33983123

Citation

Hollander-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.

Results Reference

derived

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

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