Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices

Cancer-Related Condition Clinical Trial

Official title:

Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04300842
• Other study ID #: N201910036
• Status: Enrolling by invitation
• Start date: December 22, 2019
• Est. completion date: December 26, 2021

Study information

• Verified date: December 2019
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: December 26, 2021
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer-Related Condition
• Fatigue

Intervention

Device:
• smart bracelet
to measure the stress, fatigue, and activity.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue	Unit of measure: severity of fatigue level; measurement tool: Brief Fatigue Index	over 5 days
Primary	Heart Rate Variability (HRV) monitor	Use a digital device to measure the heart rate variability and calculate the HRV data	over 5 days
Secondary	Distress Thermometer(DT)	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
Secondary	Leeds Sleep Evaluation Questionnaire(LSEQ)	To assess sleep quality, higher scores mean more disrupt sleep.	over 5 days
Secondary	International Physical Activity Questionnaire(IPAQ)	Life activity survey	over 5 days
Secondary	Perceived Stress Scale (PSS)	higher scores mean more stressful condition	over 5 days