Using Wearable Device to Improve Quality of Palliative Care

NCT ID: NCT05054907

Last Updated: 2022-11-09

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

UNKNOWN

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-23

Study Completion Date

2023-04-30

Brief Summary

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This study is going to use wearable devices and smartphones to collect physical data from terminal patients and build a survival predicting model for terminal patients with machine learning. Investigators hypothesize that continuous physical data monitoring could offer a hint to better predictability in end-of-life care.

Detailed Description

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The study aim to examine the feasibility of utilizing wearable devices and smartphones in palliative patients in Taiwan. In addition, investigators try to identify the relationship between mobile health data and disease progression and establish a predicting model to the emergent medical need and death of patients, via machine learning.

This is a single-arm observational study using wearable devices and smartphones in terminal cancer patients. Investigators planned to enroll 75 patients who receive palliative care. After obtaining consent from the patients or their legally authorized surrogate decision-makers, a baseline assessment will be conducted, with a guide to use wearable devices and phone apps.

Investigators will keep regular follow-up for 52 weeks or until the participants' death. Assessment will be conducted every week, face-to-face or by telephone contact. A routine assessment includes symptoms and functionality in the past week, and vital signs and facial photograph will be recorded if possible. Physical data measured from wearable devices would be recorded continuously. The emergent medical needs of patient, including emergency department visit, unplanned admission and death of participants will be recorded if happen.

The primary outcome is the predictive performance (sensitivity and specificity) of the machine-learning model using wearable device data and symptoms assessment. The secondary outcomes are symptoms, including pain, dyspnea, diarrhea, constipation, nausea, vomiting, insomnia, depression, anxiety and fatigue. Users' opinion and comment to using experience will also be recorded.

Conditions

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Terminal Cancer End Stage Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Wearable devices + Smartphone

The only arm in the study.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age: 20 years old or older
* Clinical diagnosis: cancer in terminal stage.

Exclusion Criteria

\- Cannot cooperate with use of wearable devices or smartphones.
Minimum Eligible Age

20 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaw-Shiun Tsai, MDPHD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status COMPLETED

National Taiwan University, Cancer Center

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jen-Hsuan Liu, MD

Role: CONTACT

+886922068868

Jaw-Shiun Tsai, MDPHD

Role: CONTACT

Facility Contacts

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Jenhsuan Liu

Role: primary

+886972654705

References

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Pavic M, Klaas V, Theile G, Kraft J, Troster G, Blum D, Guckenberger M. Mobile Health Technologies for Continuous Monitoring of Cancer Patients in Palliative Care Aiming to Predict Health Status Deterioration: A Feasibility Study. J Palliat Med. 2020 May;23(5):678-685. doi: 10.1089/jpm.2019.0342. Epub 2019 Dec 23.

Reference Type BACKGROUND
PMID: 31873052 (View on PubMed)

Liu JH, Shih CY, Huang HL, Peng JK, Cheng SY, Tsai JS, Lai F. Evaluating the Potential of Machine Learning and Wearable Devices in End-of-Life Care in Predicting 7-Day Death Events Among Patients With Terminal Cancer: Cohort Study. J Med Internet Res. 2023 Aug 18;25:e47366. doi: 10.2196/47366.

Reference Type DERIVED
PMID: 37594793 (View on PubMed)

Other Identifiers

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202105097RIND

Identifier Type: -

Identifier Source: org_study_id

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