Cancer Related FatigueNCT05696275
Using Combine Walking and Elastic Band to Decrease Fatigue
A study testing exercise in people with Cancer Related Fatigue, run by Taipei Medical University at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer Related Fatigue
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Oct 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20 years old;
- diagnosis of cancer;
- can continuous wearing bracelet for 14 days or more
Who cannot join
- Unclear and unable to answer the questionnaire；
- Not able to walk；
- platelet <50,000/mm3；
- ANC 500/cumm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue
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.
- Conditions
- Cancer Related Fatigue
- Being tested
- exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
20-30 minutes of walking and elastic band exercise per day
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | combine walking and elastic band exercise Receives: Behavioral: exercise |
| usual care | No intervention | as usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
cancer fatigue--BFI
severity of fatigue level; measurement tool: Brief Fatigue Index
Measured: Change from Baseline post exercise 5 min
cancer fatigue--BFI
severity of fatigue level; measurement tool: Brief Fatigue Index
Measured: Change from Baseline at 1 month.
Secondary outcomes (13)
Physical Activity assessment--IPAQ
International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.
Measured: Change from Baseline post exercise 5 min
Physical Activity assessment--IPAQ
International Physical Activity Questionnaire (IPAQ), the questionnaire consists of seven questions regarding types of physical activity that constitute elements of everyday life. The questions refer to physical activity in the last seven days and concern the time spent sitting and walking as well as the time devoted to vigorous and moderate physical activity. Activities done for at least 10 min at a time are taken into account. This instrument is used to assess physical activity levels-according to the IPAQ scoring protocol, three levels are distinguished, i.e., low, moderate and high.
Measured: Change from Baseline at 1 month.
Chinese version of the Edmonton Symptom Assessment System，C-ESAS
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Measured: Change from Baseline post exercise 5 min
Chinese version of the Edmonton Symptom Assessment System，C-ESAS
The ESAS includes 11 symptoms: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, sleep, well-being, shortness of breath, and other. It uses a 0-10 numerical scale: 0 shows the absence of a symptom, and 10 shows the worst experience of the symptom.
Measured: Change from Baseline at 1 month.
Sleep quality--PSQI
Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.
Measured: Change from Baseline post exercise 5 min
Sleep quality--PSQI
Pittsburgh Sleep Quality Index (PSQI) scores, is used to assess the quality of sleep of patients - with scores ranging from 0 to 21 - with lower scores indicating better sleep quality.
Measured: Change from Baseline at 1 month.
Steps count
more steps means good for ability
Measured: Change from Baseline post exercise 5 min
Steps count
more steps means good for ability
Measured: Change from Baseline at 1 month.
walking distance
Longer distances mean better movement
Measured: Change from Baseline post exercise 5 min
walking distance
Longer distances mean better movement
Measured: Change from Baseline at 1 month.
strength ability
Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
Measured: Change from Baseline post exercise 5 min
strength ability
Muscle strength is measured with a muscle strength meter, and an increase in value means an increase in muscle strength
Measured: Change from Baseline at 1 month.
Smart bracelet_Heart rate variability (HRV)
HRV is the physiological phenomenon of the variation in the time interval between consecutive heartbeats in milliseconds. A normal, healthy heart does not tick evenly like a metronome, but instead, when looking at the milliseconds between heartbeats, there is constant variation.
Measured: Continue wear bracelet five days to record HRV data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start26 Oct 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai-Wei Huang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696275
- Sponsor's protocol ID
- N202208012
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-aided Caring System With Dual-mode Assessment Method Using ePRO and Wearables for Cancer-related Fatigue
- ClinicalTrials.gov ID
- NCT05696275
- Acronym / sponsor ID
- N202208012
- Conditions
- Cancer Related Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: exercisecombine walking and elastic band exercise |
| usual care | No intervention | –as usual care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 20 years old;
- diagnosis of cancer;
- can continuous wearing bracelet for 14 days or more
Key exclusion criteria (4 listed)
- Unclear and unable to answer the questionnaire；
- Not able to walk；
- platelet <50,000/mm3；
- ANC 500/cumm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise20-30 minutes of walking and elastic band exercise per day | Behavioural | exercise |
Primary outcome
cancer fatigue--BFI
Time frame: Change from Baseline post exercise 5 min
severity of fatigue level; measurement tool: Brief Fatigue Index
cancer fatigue--BFI
Time frame: Change from Baseline at 1 month.
severity of fatigue level; measurement tool: Brief Fatigue Index
13 secondary outcomes
Physical Activity assessment--IPAQ
Time frame: Change from Baseline post exercise 5 min
Physical Activity assessment--IPAQ
Time frame: Change from Baseline at 1 month.
Chinese version of the Edmonton Symptom Assessment System，C-ESAS
Time frame: Change from Baseline post exercise 5 min
Chinese version of the Edmonton Symptom Assessment System，C-ESAS
Time frame: Change from Baseline at 1 month.
Sleep quality--PSQI
Time frame: Change from Baseline post exercise 5 min
Sleep quality--PSQI
Time frame: Change from Baseline at 1 month.
Steps count
Time frame: Change from Baseline post exercise 5 min
Steps count
Time frame: Change from Baseline at 1 month.
walking distance
Time frame: Change from Baseline post exercise 5 min
walking distance
Time frame: Change from Baseline at 1 month.
strength ability
Time frame: Change from Baseline post exercise 5 min
strength ability
Time frame: Change from Baseline at 1 month.
Smart bracelet_Heart rate variability (HRV)
Time frame: Continue wear bracelet five days to record HRV data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Cancer Related Fatigue, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer fatigue--BFI (time frame: Change from Baseline post exercise 5 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.