Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices

March 5, 2020 updated by: Taipei Medical University
This project expects to enroll 60 cancer patients, 60 healthy people and their subjective-objective measurements on fatigue, stress, and total steps will be validated so that the information can be used in further care and improvement of life of quality of the patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 110
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients with some cancer treatment side effects. Healthy people compare with cancer patients who no cancer disease now.

Description

Inclusion Criteria:

  • Age ≧ 20 years old;
  • One group had a cancer diagnosis, one group no cancer diagnosis;
  • Can continuous wearing bracelet for 5 days or more

Exclusion Criteria:

  • Unclear and unable to answer the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer patient
This project expects to enroll 60 cancer patients and their subjective-objective measurements on fatigue, stress, and total steps will be observed.
Device: smart bracelet
to measure the stress, fatigue, and activity.
Healthy population
This project expects to enroll 60 healthy population and their subjective-objective measurements on fatigue, stress, and total steps will be observed.
Device: smart bracelet
to measure the stress, fatigue, and activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue
Time Frame: over 5 days
Unit of measure: severity of fatigue level; measurement tool: Brief Fatigue Index
over 5 days
Heart Rate Variability (HRV) monitor
Time Frame: over 5 days
Use a digital device to measure the heart rate variability and calculate the HRV data
over 5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress Thermometer(DT)
Time Frame: over 5 days
a screening measure to identify and address psychological distress in individuals with cancer. a cutoff score of 3 on the DT to indicate patients with clinically elevated levels of distress.
over 5 days
Leeds Sleep Evaluation Questionnaire(LSEQ）
Time Frame: over 5 days
To assess sleep quality, higher scores mean more disrupt sleep.
over 5 days
International Physical Activity Questionnaire(IPAQ）
Time Frame: over 5 days
Life activity survey
over 5 days
Perceived Stress Scale (PSS）
Time Frame: over 5 days
higher scores mean more stressful condition
over 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2019

Primary Completion (Anticipated)

December 26, 2020

Study Completion (Anticipated)

December 26, 2021

Study Registration Dates

First Submitted

December 22, 2019

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201910036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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