Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study

October 26, 2023 updated by: Helle Pappot, Rigshospitalet, Denmark
The study will assess the feasibility of using the ChronolifeTM smart t-shirt for home monitoring of vital parameters in cancer patients during their treatment course. This study will bring new insights to how wearables and biometric data can be used as a part of symptom recognition in cancer patients during treatment course in the quest of increasing patients' quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Collecting biometric sensor data by wearables is an example of real-time patient-generated health data that can provide vital and detailed objective information about patients. This may have the potential to improve quality of oncological treatment and increase patients' quality of life.

Studies have shown that there may be a dissimilar perception on symptoms and side effects between patients and health care professionals. Wearables may help identifying symptoms earlier.

A new design of a wearable is a smart t-shirt. A smart t-shirt has sensors embedded in the fabric which generate measurement flows. This new tool provide more precise information without recall and reporting bias which may have the potential to lead to a better and more accurate cancer treatment.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 3450
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Danish cancer patients ≥18 years in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark
  • Both patients in curative and palliative care will be eligible
  • 10 cancer patients under 39 years
  • 10 cancer patients over 65 years
  • Able to read and speak Danish

Exclusion Criteria:

  • Serious cognitive deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Smart shirt
The research intervention is, for all twenty patients, to wear a smart t-shirt connected to a smart phone throughout the day (preferably 8 hours pr day) for 2 weeks.
Device: Wearable sensor
The patients will be asked to wear a smart shirt. The shirt is designed with multiple sensors and electrodes fully embedded which engender 6 different measurement flows continuously. The smart t-shirt system is washable, and patients can wash and dry this t-shirt anytime, thus the shirt can be worn repeatedly.
Other Names:
  • ChronolifeTM Smart t-shirt
  • OncoSmartShirt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period
Time Frame: 2 weeks
To assess the feasibility of using the ChronolifeTM smart t-shirt based on the completion rate which is defined as the number of included patients using the smart t-shirt at least 12 hours pr. day during the three weeks study period.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical feasibility
Time Frame: 2 weeks
To assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in heart rate
Time Frame: 2 weeks
Changes in heart rate (beat per minute) will be presented descriptively.
2 weeks
Changes in skin temperature
Time Frame: 2 weeks
Changes in skin temperature (°C) will be presented descriptively.
2 weeks
Changes in physical activity
Time Frame: 2 weeks
Changes in physical activity (steps) will be presented descriptively.
2 weeks
Changes in respirations frequency
Time Frame: 2 weeks
Changes in respirations frequency (respiration per minute) will be presented descriptively.
2 weeks
Changes in thoracic impedance
Time Frame: 2 weeks
Changes in thoracic impedance (kOhm) will be presented descriptively.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Cecilie Holländer-Mieritz, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OncoSmartShirt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe