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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Device: Wearable sensor

• Registration Number: NCT05235594
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

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 Timeline

• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-10
• Study First Posted: 2022-02-11
• Study Start: 2022-03-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-10-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Smart shirt	Wearable sensor	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.

Primary Outcome Measures

Name	Time	Method
Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period	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.

Secondary Outcome Measures

Name	Time	Method
Technical feasibility	2 weeks	To assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark