NCT05696275

Brief Summary

This study is expected to propose an industry-university cooperation research case for the next two years. When cancer patients use ePRO to record subjective fatigue, and smart watches with 4G communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. Suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. This study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. To sum up, the first-year plan is expected to use the established ePRO electronic records, combined with the LINE communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, Establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 26, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

November 16, 2022

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • cancer fatigue--BFI

    severity of fatigue level; measurement tool: Brief Fatigue Index

    Change from Baseline post exercise 5 min

  • cancer fatigue--BFI

    severity of fatigue level; measurement tool: Brief Fatigue Index

    Change from Baseline at 1 month.

Secondary Outcomes (13)

  • Physical Activity assessment--IPAQ

    Change from Baseline post exercise 5 min

  • Physical Activity assessment--IPAQ

    Change from Baseline at 1 month.

  • Chinese version of the Edmonton Symptom Assessment System,C-ESAS

    Change from Baseline post exercise 5 min

  • Chinese version of the Edmonton Symptom Assessment System,C-ESAS

    Change from Baseline at 1 month.

  • Sleep quality--PSQI

    Change from Baseline post exercise 5 min

  • +8 more secondary outcomes

Study Arms (2)

exercise

EXPERIMENTAL

combine walking and elastic band exercise

Behavioral: exercise

usual care

NO INTERVENTION

as usual care

Interventions

exerciseBEHAVIORAL

20-30 minutes of walking and elastic band exercise per day

exercise

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 20 years old;
  • diagnosis of cancer;
  • can continuous wearing bracelet for 14 days or more

You may not qualify if:

  • Unclear and unable to answer the questionnaire;
  • Not able to walk;
  • platelet \<50,000/mm3;
  • ANC 500/cumm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wan Fang Hospital

Taipei, Taiwan, 110, Taiwan

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2022

First Posted

January 25, 2023

Study Start

October 26, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations