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

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: Cancer
• Intervention / Treatment: Device: Wearable sensor

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

Study Locations

• Denmark
  • Copenhagen, Denmark, 3450
    • Rigshospitalet

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Steen-Olsen EB, Pappot H, Green A, Langberg H, Hollander-Mieritz C. Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study. JMIR Res Protoc. 2022 Oct 3;11(10):e37626. doi: 10.2196/37626.

Study record dates

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: Patient reported outcomes; Cancer; Wearable; Smart t-shirt; Patient-generated health data; Biometric sensor technology
• 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