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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235594
• Other study ID #: OncoSmartShirt
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in heart rate	Changes in heart rate (beat per minute) will be presented descriptively.	2 weeks
Other	Changes in skin temperature	Changes in skin temperature (°C) will be presented descriptively.	2 weeks
Other	Changes in physical activity	Changes in physical activity (steps) will be presented descriptively.	2 weeks
Other	Changes in respirations frequency	Changes in respirations frequency (respiration per minute) will be presented descriptively.	2 weeks
Other	Changes in thoracic impedance	Changes in thoracic impedance (kOhm) will be presented descriptively.	2 weeks
Primary	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	Technical feasibility	To assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.	2 weeks