Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05235594
Enrollment
10
Registered
2022-02-11
Start date
2022-03-01
Completion date
2022-10-01
Last updated
2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Patient reported outcomes, Smart t-shirt, Wearable, Patient-generated health data, Biometric sensor technology, Cancer

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.

Interventions

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.

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period2 weeksTo 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

MeasureTime frameDescription
Technical feasibility2 weeksTo assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.

Other

MeasureTime frameDescription
Changes in heart rate2 weeksChanges in heart rate (beat per minute) will be presented descriptively.
Changes in thoracic impedance2 weeksChanges in thoracic impedance (kOhm) will be presented descriptively.
Changes in physical activity2 weeksChanges in physical activity (steps) will be presented descriptively.
Changes in skin temperature2 weeksChanges in skin temperature (°C) will be presented descriptively.
Changes in respirations frequency2 weeksChanges in respirations frequency (respiration per minute) will be presented descriptively.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026