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

NCT ID: NCT05235594

Last Updated: 2023-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-10-01

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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental: Smart shirt

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.

Group Type EXPERIMENTAL

Wearable sensor

Intervention Type 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.

Interventions

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Wearable sensor

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.

Intervention Type DEVICE

Other Intervention Names

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ChronolifeTM Smart t-shirt OncoSmartShirt

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Helle Pappot

Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cecilie Holländer-Mieritz, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36190744 (View on PubMed)

Other Identifiers

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OncoSmartShirt

Identifier Type: -

Identifier Source: org_study_id

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