Cancer-Related ConditionNCT04843657
Precise Care for Cancer Related Fatigue
An observational study of Cancer-Related Condition, run by Taipei Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Cancer-Related Condition
- What is being tested?
- Observation for symptom distress
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2021to 31 Jul 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with some cancer treatment side effects.
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 7 days or more
Who cannot join
- Unclear and unable to answer the questionnaire
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Objective Data for Cancer Related Fatigue in Cancer Patients
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.
- Conditions
- Cancer-Related Condition
- Being tested
- Observation for symptom distress
- Keywords
- Cancer-related fatigue, smart bracelet device, symptoms for subjective and objective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation for symptom distressBehavioural
Observation for symptom distress
What is being measured
The primary outcome is the main question the study is designed to answer.
fatigue
severity of fatigue level; measurement tool: Brief Fatigue Index
Measured: 7-8 days
Heart Rate Variability (HRV) monitor
Use a digital device to measure the heart rate variability and calculate the HRV data
Measured: 7-8 days
Secondary outcomes (5)
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: 7-8 days
Leeds Sleep Evaluation Questionnaire(LSEQ）
To assess sleep quality, higher scores mean more disrupt sleep.
Measured: 7-8 days
International Physical Activity Questionnaire(IPAQ）
Life activity survey
Measured: 7-8 days
Perceived Stress Scale (PSS）
higher scores mean more stressful condition
Measured: 7-8 days
ESAS (Edmonton Symptom Assessment Scale)
higher scores mean more severe symptoms condition
Measured: 7-8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start15 Apr 2021 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2024 (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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsai-Wei Huang, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843657
- Sponsor's protocol ID
- cancer related fatigue monitor
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Data for Cancer Related Fatigue in Cancer Patients
- ClinicalTrials.gov ID
- NCT04843657
- Acronym / sponsor ID
- cancer related fatigue monitor
- Conditions
- Cancer-Related Condition
- Keywords
- Cancer-related fatigue, smart bracelet device, symptoms for subjective and objective
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 13 Apr 2021 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with some cancer treatment side effects.
Key inclusion criteria (1 listed)
- Age ≧ 20 years old; One group had a cancer diagnosis, one group no cancer diagnosis; Can continuous wearing bracelet for 7 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 |
|---|---|---|
| Observation for symptom distressObservation for symptom distress | Behavioural | – |
Primary outcome
fatigue
Time frame: 7-8 days
severity of fatigue level; measurement tool: Brief Fatigue Index
Heart Rate Variability (HRV) monitor
Time frame: 7-8 days
Use a digital device to measure the heart rate variability and calculate the HRV data
5 secondary outcomes
Distress Thermometer(DT)
Time frame: 7-8 days
Leeds Sleep Evaluation Questionnaire(LSEQ）
Time frame: 7-8 days
International Physical Activity Questionnaire(IPAQ）
Time frame: 7-8 days
Perceived Stress Scale (PSS）
Time frame: 7-8 days
ESAS (Edmonton Symptom Assessment Scale)
Time frame: 7-8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer-Related Condition
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
RecruitingPhase 2
CASCADE 2002: PROTECT Study, "PRObiotics to TrEat Anal preCancer Trial
HSIL, High Grade Squamous Intraepithelial Lesion, HPV-Related Squamous Cell Carcinoma
Not yet recruitingObservational study
Chinese Multicenter Registry for Peutz-Jeghers Syndrome
Peutz-Jeghers Syndrome
Active, not recruitingPhase 2
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
Melanoma Stage III, Melanoma Stage IV
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.
Tsai-Wei Huang principal investigator
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-Related Condition, run by Taipei Medical University.
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 1 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Tsai-Wei Huang (+88627361661, tsaiwei@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue (time frame: 7-8 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 13 Apr 2021.