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Completed

NCT Number: NCT05235594

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 3450, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ChronolifeTM Smart t-shirt, OncoSmartShirt

Primary outcomes

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

    Time frame: 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 outcomes

  1. Technical feasibility

    Time frame: 2 weeks

    To assess technical feasibility in a Danish healthcare system including data acquisition rate and data completeness.

Other outcomes

  1. Changes in heart rate

    Time frame: 2 weeks

    Changes in heart rate (beat per minute) will be presented descriptively.

  2. Changes in skin temperature

    Time frame: 2 weeks

    Changes in skin temperature (°C) will be presented descriptively.

  3. Changes in physical activity

    Time frame: 2 weeks

    Changes in physical activity (steps) will be presented descriptively.

  4. Changes in respirations frequency

    Time frame: 2 weeks

    Changes in respirations frequency (respiration per minute) will be presented descriptively.

  5. Changes in thoracic impedance

    Time frame: 2 weeks

    Changes in thoracic impedance (kOhm) will be presented descriptively.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 11, 2022
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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