Cancer-Related ConditionNCT04300842
Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices
An observational study of Cancer-Related Condition, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer-Related Condition
- What is being tested?
- smart bracelet
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Dec 2019to 26 Dec 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cancer patients with some cancer treatment side effects. Healthy people compare with cancer patients who no cancer disease now.
Who may be able to join
- Age ≧ 20 years old;
- One group had a cancer diagnosis, one group no cancer diagnosis;
- Can continuous wearing bracelet for 5 days or more
Who cannot join
- Unclear and unable to answer the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer-Related Condition
- Being tested
- smart bracelet
- Keywords
- Cancer-related fatigue, smart bracelet device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart braceletDevice
to measure the stress, fatigue, and activity.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patient | This project expects to enroll 60 cancer patients and their subjective-objective measurements on fatigue, stress, and total steps will be observed. Receives: 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. Receives: Device: smart bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
Unit of measure: severity of fatigue level; measurement tool: Brief Fatigue Index
Measured: over 5 days
Heart Rate Variability (HRV) monitor
Use a digital device to measure the heart rate variability and calculate the HRV data
Measured: over 5 days
Secondary outcomes (4)
Distress Thermometer(DT)
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.
Measured: over 5 days
Leeds Sleep Evaluation Questionnaire(LSEQ）
To assess sleep quality, higher scores mean more disrupt sleep.
Measured: over 5 days
International Physical Activity Questionnaire(IPAQ）
Life activity survey
Measured: over 5 days
Perceived Stress Scale (PSS）
higher scores mean more stressful condition
Measured: over 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start22 Dec 2019
- Primary completion26 Dec 2020 (estimated)
- Study completion26 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-Related ConditionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300842
- Sponsor's protocol ID
- N201910036
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Fatigue in Cancer Patients Using Smart Bracelet Devices
- ClinicalTrials.gov ID
- NCT04300842
- Acronym / sponsor ID
- N201910036
- Conditions
- Cancer-Related Condition
- Keywords
- Cancer-related fatigue, smart bracelet device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 26 Dec 2020 (estimated)
- Study completion
- 26 Dec 2021 (estimated)
- First posted
- 9 Mar 2020 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer patient | – | Device: smart braceletThis project expects to enroll 60 cancer patients and their subjective-objective measurements on fatigue, stress, and total steps will be observed. |
| Healthy population | – | Device: smart braceletThis project expects to enroll 60 healthy population and their subjective-objective measurements on fatigue, stress, and total steps will be observed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with some cancer treatment side effects. Healthy people compare with cancer patients who no cancer disease now.
Key inclusion criteria (3 listed)
- Age ≧ 20 years old;
- One group had a cancer diagnosis, one group no cancer diagnosis;
- Can continuous wearing bracelet for 5 days or more
Key exclusion criteria (1 listed)
- Unclear and unable to answer the questionnaire
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 |
|---|---|---|
| smart braceletto measure the stress, fatigue, and activity. | Device | Cancer patient, Healthy population |
Primary outcome
fatigue
Time frame: over 5 days
Unit of measure: severity of fatigue level; measurement tool: Brief Fatigue Index
Heart Rate Variability (HRV) monitor
Time frame: over 5 days
Use a digital device to measure the heart rate variability and calculate the HRV data
4 secondary outcomes
Distress Thermometer(DT)
Time frame: over 5 days
Leeds Sleep Evaluation Questionnaire(LSEQ）
Time frame: over 5 days
International Physical Activity Questionnaire(IPAQ）
Time frame: over 5 days
Perceived Stress Scale (PSS）
Time frame: over 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Cancer-Related Condition, 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 1 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: status not confirmed, as of the sponsor's last update on 9 Mar 2020. 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?
Results are not available in the source record.
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?
fatigue (time frame: over 5 days). 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 9 Mar 2020.