Precise Care for Cancer Related Fatigue

Sponsor

Taipei Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04843657

Collaborator

(none)

200

Enrollment

39.5

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer-Related Condition	Behavioral: Observation for symptom distress

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Objective Data for Cancer Related Fatigue in Cancer Patients

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Outcome Measures

Primary Outcome Measures

fatigue [7-8 days]
severity of fatigue level; measurement tool: Brief Fatigue Index
Heart Rate Variability (HRV) monitor [7-8 days]
Use a digital device to measure the heart rate variability and calculate the HRV data

Secondary Outcome Measures

Distress Thermometer(DT) [7-8 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.
Leeds Sleep Evaluation Questionnaire(LSEQ） [7-8 days]
To assess sleep quality, higher scores mean more disrupt sleep.
International Physical Activity Questionnaire(IPAQ） [7-8 days]
Life activity survey
Perceived Stress Scale (PSS） [7-8 days]
higher scores mean more stressful condition
ESAS (Edmonton Symptom Assessment Scale) [7-8 days]
higher scores mean more severe symptoms condition

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taipei Medical University

Investigators

Principal Investigator: Tsai-Wei Huang, Taipei Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Taipei Medical University

ClinicalTrials.gov Identifier:

NCT04843657

Other Study ID Numbers:

cancer related fatigue monitor

First Posted:

Apr 13, 2021

Last Update Posted:

Apr 13, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Taipei Medical University

Cancer-related fatigue

smart bracelet device

symptoms for subjective and objective

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Apr 13, 2021