Clinical trial NCT05235594: Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study
Official title: Feasibility of Monitoring Cancer Patients With a Smart T-shirt: Protocol for the OncoSmartShirt Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Patient reported outcomes
Smart t-shirt
Wearable
Patient-generated health data
Biometric sensor technology
Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who could wear the smart t-shirt preferably 8 hours pr. day during the three weeks study period
timeFrame: 2 weeks
Secondary outcomes:
measure: Technical feasibility
timeFrame: 2 weeks
Other outcomes:
measure: Changes in heart rate
timeFrame: 2 weeks
measure: Changes in skin temperature
timeFrame: 2 weeks
measure: Changes in physical activity
timeFrame: 2 weeks
measure: Changes in respirations frequency
timeFrame: 2 weeks
measure: Changes in thoracic impedance
timeFrame: 2 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Cecilie Holländer-Mieritz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.