Precise Care for Cancer Related Fatigue

Cancer-Related Condition Clinical Trial

Official title:

Objective Data for Cancer Related Fatigue in Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04843657
• Other study ID #: cancer related fatigue monitor
• Status: Not yet recruiting
• Start date: April 15, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2021
• Source: Taipei Medical University
• Contact: Tsai-Wei Huang
• Phone: +88627361661
• Email: tsaiwei[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project expects to enroll 200 cancer patients and their subjective-objective measurements on fatigue, stress, symptoms, 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: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age ? 20 years old; One group had a cancer diagnosis, one group no cancer diagnosis; Can continuous wearing bracelet for 7 days or more

Exclusion Criteria:

• Unclear and unable to answer the questionnaire

Related Conditions & MeSH terms

• Cancer-Related Condition
• Fatigue

Intervention

Behavioral:
• Observation for symptom distress
Observation for symptom distress

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue	severity of fatigue level; measurement tool: Brief Fatigue Index	7-8 days
Primary	Heart Rate Variability (HRV) monitor	Use a digital device to measure the heart rate variability and calculate the HRV data	7-8 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.	7-8 days
Secondary	Leeds Sleep Evaluation Questionnaire(LSEQ)	To assess sleep quality, higher scores mean more disrupt sleep.	7-8 days
Secondary	International Physical Activity Questionnaire(IPAQ)	Life activity survey	7-8 days
Secondary	Perceived Stress Scale (PSS)	higher scores mean more stressful condition	7-8 days
Secondary	ESAS (Edmonton Symptom Assessment Scale)	higher scores mean more severe symptoms condition	7-8 days