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

NCT05235594 | Completed

• 1 other identifier: OncoSmartShirt
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Technical feasibility

  2 weeks

Other Outcomes (5)

• Changes in heart rate

  2 weeks

• Changes in skin temperature

  2 weeks

• Changes in physical activity

  2 weeks

Study Arms (1)

Experimental: Smart shirt

EXPERIMENTAL

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

Interventions

Wearable sensor DEVICE

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.

Also known as: ChronolifeTM Smart t-shirt, OncoSmartShirt

Experimental: Smart shirt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Danish cancer patients ≥18 years in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark
• Both patients in curative and palliative care will be eligible
• cancer patients under 39 years
• cancer patients over 65 years
• Able to read and speak Danish

You may not qualify if:

• Serious cognitive deficits

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 3450, Denmark

Location

Related Publications (1)

• 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.

  PMID: 36190744 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Cecilie Holländer-Mieritz, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 11, 2022
• Study Start: March 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)