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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Device: Wearable sensor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Smart shirt<br>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<br>* 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.<br>* Other names: OncoSmartShirt;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient reported outcomes, Smart t-shirt, Wearable, Patient-generated health data, Biometric sensor technology, Cancer