NCT04843657

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

April 12, 2021

Last Update Submit

April 12, 2021

Conditions

Cancer-Related Condition

Keywords

Cancer-related fatiguesmart bracelet devicesymptoms for subjective and objective

Outcome Measures

Primary Outcomes (2)

  • fatigue

    severity of fatigue level; measurement tool: Brief Fatigue Index

    7-8 days

  • Heart Rate Variability (HRV) monitor

    Use a digital device to measure the heart rate variability and calculate the HRV data

    7-8 days

Secondary Outcomes (5)

  • Distress Thermometer(DT)

    7-8 days

  • Leeds Sleep Evaluation Questionnaire(LSEQ）

    7-8 days

  • International Physical Activity Questionnaire(IPAQ）

    7-8 days

  • Perceived Stress Scale (PSS）

    7-8 days

  • ESAS (Edmonton Symptom Assessment Scale)

    7-8 days

Interventions

Observation for symptom distressBEHAVIORAL

Observation for symptom distress

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients with some cancer treatment side effects.

You may qualify if:

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

You may not qualify if:

  • \- Unclear and unable to answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiota

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Tsai-Wei Huang

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsai-Wei Huang

CONTACT

+88627361661tsaiwei@tmu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 13, 2021

Study Start

April 15, 2021

Primary Completion

July 31, 2023

Study Completion

July 31, 2024

Last Updated

April 13, 2021

Record last verified: 2021-04