Cancer PainNCT04053608
Human Physiology and Self-Reported Pain Score
An observational study of Cancer Pain, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
To assess whether the patient's self-reported pain level is associated with a multivariate physiological biomarker bias achieved in the actual clinical setting. This study will use a clinical-grade wearable sensor to continuously monitor the patient's physiological condition (pain-related biomarkers) and use the… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Cancer Pain
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2019to 14 Mar 2020
- 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are moderate to severe cancer pain (digital rating scale NRS ≥ 4).
Who may be able to join
- There are moderate to severe cancer pain (digital rating scale NRS ≥ 4).
- Male and female between the ages of 21 and 70
- Cancer patients diagnosed with moderate to severe cancer pain (digital rating scale NRS ≥ 4)
- Ability to provide informed consent
- Be able to commit to using the app during the study and input data as needed
- The subject must have a smart phone such as an iPhone/iPad (at least iPhone 5S)
Who cannot join
- Previously had myocardial infarction (MI)
- Coronary artery disease is known - previous coronary angioplasty
- A previous stroke occurred, and stroke was defined as a new localized nerve defect lasting more than 24 hours.
- Currently using more than 2 kinds of blood pressure lowering drugs
- Expected life is less than 1 year
- Suffering from asthma or chronic lung disease requires long-term medication or oxygen therapy
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- suffering from mental illness, the clinical judgment of the host will affect the participation of the trial, such as dementia
- Unable to comply with the test plan
- Any other acute or chronic medical/physiological condition identified by the moderator as affecting the test results
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Chih Cheng Wu, Master, 886-4-23592525 ext. 4101, chihcheng.wu@gmail.com
About this study
Official title: Observation of In-Hospital/ In-Home Continuous Monitoring of Human Physiology and Self-Reported Pain Score Among Patients With Moderate-to-severe Cancer Pain
To assess whether the patient's self-reported pain level is associated with a multivariate physiological biomarker bias achieved in the actual clinical setting. This study will use a clinical-grade wearable sensor to continuously monitor the patient's physiological condition (pain-related biomarkers) and use the mobile app to allow participants to actively report their pain scores, symptoms and quality of life.After analysis of the biomarkers we may predict the coming pain attacks by way of the meaningful biomarkers.
Read the detailed description
Subjective scores have traditionally been used to measure human pain, such as the visual analog scale (VAS) to determine the presence or absence of pain and its severity. People can only express the pain experienced by dictation, scale, and image depicting the degree of pain. Although this is important information, the self-evaluation method has problems for diagnosis and research purposes. The results of a person's self-assessment depend on past pain experiences and many other cognitive and behavioral factors and therefore change over time. In addition, it is difficult to obtain a reliable comparison between the rewards of different people. When the patient complains of a certain degree of pain, it is impossible to know whether it is equivalent to the same pain described by other patients. Moreover, it is difficult to obtain self-evaluation results among ethnic groups of different natures, such as young people, patients who block the transmission of ideas due to different disease types, and those who are unconscious. A variety of survey-based pain scales and functions have been developed recently, and the utility has improved.
However, because it is still based on self-assessment, it will leave some of the same problems with self-assessment. Developmental measurements of biomarkers or surrogate markers with acute and/or chronic pain have made significant progress over the past few years. Thanks to the development of new and improved technologies, such as in the field of angiography and wearable biosensors, there has been considerable development. Studies have shown that pupils respond to a variety of different stimuli and may predict the presence of pain. There are many different physiological parameters, such as changes in heart rate, pulsating components of the heart cycle, and skin activity, which have been shown to be associated with the presence or absence of pain. From the development of research in this field, it is feasible to develop clinical tools for measuring the presence or absence of acute and/or chronic pain, including cancer pain, using biomarkers or surrogate markers. This objective tool can make more significant advances in clinical pain research and treatment.
- Conditions
- Cancer Pain
- Medical subject headings
- Cancer Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Reporting by pain intensity and body map
Patient will report pain intensity in Numerical Rating Scale (NRS) from 0-10 through smartphone and when they suffer from pain. If possible they will type in the medications they take when they suffer from moderate (NRS>=4) to severe pain (NRS>=7). Besides, they may choosing the location of pain using a validated body map and logging the time the pain event took place to the nearest 15 minutes.
Measured: 30days
Secondary outcomes (1)
Symptom Reporting and record of EQ-5D-3L (Quality of Life Questionnaire)
There are 5 dimensions in the record of EQ-5D-3L (3-level version of the EuroQol-5 Dimension of health questionnaire) including mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. There are 3 severity levels (no such problem, some problems/ moderately affected, unable to perform activities or extremely affected) in each dimensions of evaluation. The labels 1-3 describe different severity levels in a dimension and are used to form part of a numerical description of a health state.
The second part is the EQ VAS (EuroQol visual analogue scale) records the respondent's self-rated health on a vertical VAS scled from 0 to 100 where the endpoints 0 and 100 are labelled 'The worst health you can imagine' and 'The best health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start8 Aug 2019
- Primary completion14 Mar 2020 (estimated)
- Study completion14 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Responsible party
- Principal investigator, Chih-Cheng Wu, Taichung Veterans General Hospital
- Investigators
- Chih Cheng Wu, Master, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053608
- Sponsor's protocol ID
- SF19052B
- Status last verified
- Aug 2019
- First submitted
- 29 Jul 2019
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of In-Hospital/ In-Home Continuous Monitoring of Human Physiology and Self-Reported Pain Score Among Patients With Moderate-to-severe Cancer Pain
- ClinicalTrials.gov ID
- NCT04053608
- Acronym / sponsor ID
- SF19052B
- Conditions
- Cancer Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Collaborators
- Taiwan Mundipharma Pharmaceuticals Ltd.
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 14 Mar 2020 (estimated)
- Study completion
- 14 Mar 2020 (estimated)
- First posted
- 12 Aug 2019 (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.
To assess whether the patient's self-reported pain level is associated with a multivariate physiological biomarker bias achieved in the actual clinical setting. This study will use a clinical-grade wearable sensor to continuously monitor the patient's physiological condition (pain-related biomarkers) and use the mobile app to allow participants to actively report their pain scores, symptoms and quality of life.After analysis of the biomarkers we may predict the coming pain attacks by way of the meaningful biomarkers.
Detailed description
Subjective scores have traditionally been used to measure human pain, such as the visual analog scale (VAS) to determine the presence or absence of pain and its severity. People can only express the pain experienced by dictation, scale, and image depicting the degree of pain. Although this is important information, the self-evaluation method has problems for diagnosis and research purposes. The results of a person's self-assessment depend on past pain experiences and many other cognitive and behavioral factors and therefore change over time. In addition, it is difficult to obtain a reliable comparison between the rewards of different people. When the patient complains of a certain degree of pain, it is impossible to know whether it is equivalent to the same pain described by other patients. Moreover, it is difficult to obtain self-evaluation results among ethnic groups of different natures, such as young people, patients who block the transmission of ideas due to different disease types, and those who are unconscious. A variety of survey-based pain scales and functions have been developed recently, and the utility has improved.
However, because it is still based on self-assessment, it will leave some of the same problems with self-assessment. Developmental measurements of biomarkers or surrogate markers with acute and/or chronic pain have made significant progress over the past few years. Thanks to the development of new and improved technologies, such as in the field of angiography and wearable biosensors, there has been considerable development. Studies have shown that pupils respond to a variety of different stimuli and may predict the presence of pain. There are many different physiological parameters, such as changes in heart rate, pulsating components of the heart cycle, and skin activity, which have been shown to be associated with the presence or absence of pain. From the development of research in this field, it is feasible to develop clinical tools for measuring the presence or absence of acute and/or chronic pain, including cancer pain, using biomarkers or surrogate markers. This objective tool can make more significant advances in clinical pain research and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are moderate to severe cancer pain (digital rating scale NRS ≥ 4).
Key inclusion criteria (6 listed)
- There are moderate to severe cancer pain (digital rating scale NRS ≥ 4).
- Male and female between the ages of 21 and 70
- Cancer patients diagnosed with moderate to severe cancer pain (digital rating scale NRS ≥ 4)
- Ability to provide informed consent
- Be able to commit to using the app during the study and input data as needed
Key exclusion criteria (9 listed)
- Previously had myocardial infarction (MI)
- Coronary artery disease is known - previous coronary angioplasty
- A previous stroke occurred, and stroke was defined as a new localized nerve defect lasting more than 24 hours.
- Currently using more than 2 kinds of blood pressure lowering drugs
- Expected life is less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Reporting by pain intensity and body map
Time frame: 30days
Patient will report pain intensity in Numerical Rating Scale (NRS) from 0-10 through smartphone and when they suffer from pain. If possible they will type in the medications they take when they suffer from moderate (NRS>=4) to severe pain (NRS>=7). Besides, they may choosing the location of pain using a validated body map and logging the time the pain event took place to the nearest 15 minutes.
1 secondary outcome
Symptom Reporting and record of EQ-5D-3L (Quality of Life Questionnaire)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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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.
Chih Cheng Wu, Master principal investigator
Taichung Veterans General Hospital
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 Pain, run by Taichung Veterans General Hospital 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 6 inclusion and 9 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 14 Aug 2019. 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?
Contact Chih Cheng Wu, Master (886-4-23592525 ext. 4101, chihcheng.wu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Reporting by pain intensity and body map (time frame: 30days). 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 Aug 2019.