Precise Care for Cancer Related Fatigue

April 12, 2021 updated by: Taipei Medical University

Objective Data for Cancer Related Fatigue in Cancer Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients with some cancer treatment side effects.

Description

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

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

April 15, 2021

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 12, 2021

First Posted (Actual)

April 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 12, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cancer related fatigue monitor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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