NCT04300842

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

December 22, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 22, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2021

Completed
Last Updated

March 9, 2020

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 22, 2019

Last Update Submit

March 5, 2020

Conditions

Cancer-Related Condition

Keywords

Cancer-related fatiguesmart bracelet device

Outcome Measures

Primary Outcomes (2)

  • fatigue

    Unit of measure: severity of fatigue level; measurement tool: Brief Fatigue Index

    over 5 days

  • Heart Rate Variability (HRV) monitor

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

    over 5 days

Secondary Outcomes (4)

  • Distress Thermometer(DT)

    over 5 days

  • Leeds Sleep Evaluation Questionnaire(LSEQ）

    over 5 days

  • International Physical Activity Questionnaire(IPAQ）

    over 5 days

  • Perceived Stress Scale (PSS）

    over 5 days

Study Arms (2)

Cancer patient

This project expects to enroll 60 cancer patients and their subjective-objective measurements on fatigue, stress, and total steps will be observed.

Device: smart bracelet

Healthy population

This project expects to enroll 60 healthy population and their subjective-objective measurements on fatigue, stress, and total steps will be observed.

Device: smart bracelet

Interventions

smart braceletDEVICE

to measure the stress, fatigue, and activity.

Cancer patientHealthy population

Eligibility Criteria

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

Cancer patients with some cancer treatment side effects. Healthy people compare with cancer patients who no cancer disease now.

You may qualify if:

  • Age ≧ 20 years old;
  • One group had a cancer diagnosis, one group no cancer diagnosis;
  • Can continuous wearing bracelet for 5 days or more

You may not qualify if:

  • Unclear and unable to answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2019

First Posted

March 9, 2020

Study Start

December 22, 2019

Primary Completion

December 26, 2020

Study Completion

December 26, 2021

Last Updated

March 9, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

Locations

TW(1)