Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices

• Conditions: Cancer-Related Condition
• Interventions: Device: smart bracelet

• Registration Number: NCT04300842
• Lead Sponsor: Taipei Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-22
• Study First Submitted: 2019-12-22
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-09
• Last Update Posted: 2020-03-09
• Primary Completion: 2020-12-26
• Study Completion: 2021-12-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy population	smart bracelet	This project expects to enroll 60 healthy population and their subjective-objective measurements on fatigue, stress, and total steps will be observed.
Cancer patient	smart bracelet	This project expects to enroll 60 cancer patients and their subjective-objective measurements on fatigue, stress, and total steps will be observed.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Leeds Sleep Evaluation Questionnaire(LSEQ）	over 5 days	To assess sleep quality, higher scores mean more disrupt sleep.
Distress Thermometer(DT)	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.
Perceived Stress Scale (PSS）	over 5 days	higher scores mean more stressful condition
International Physical Activity Questionnaire(IPAQ）	over 5 days	Life activity survey

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei, Taiwan