Clinical trial · Observational
Human Physiology and Self-Reported Pain Score
Observation of In-Hospital/ In-Home Continuous Monitoring of Human Physiology and Self-Reported Pain Score Among Patients With Moderate-to-severe Cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pain Reporting by pain intensity and body map
- timeFrame
- 30days
- description
- 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.
Secondary outcomes (1)
- measure
- Symptom Reporting and record of EQ-5D-3L (Quality of Life Questionnaire)
- timeFrame
- 30 days
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: There are moderate to severe cancer pain (digital rating scale NRS ≥ 4). Inclusion conditions: 1. Male and female between the ages of 21 and 70 2. Cancer patients diagnosed with moderate to severe cancer pain (digital rating scale NRS ≥ 4) 3. Ability to provide informed consent 4. Be able to commit to using the app during the study and input data as needed 5. The subject must have a smart phone such as an iPhone/iPad (at least iPhone 5S) Exclusion Criteria: 1. Previously had myocardial infarction (MI) 2. Coronary artery disease is known - previous coronary angioplasty 3. A previous stroke occurred, and stroke was defined as a new localized nerve defect lasting more than 24 hours. 4. Currently using more than 2 kinds of blood pressure lowering drugs 5. Expected life is less than 1 year 6. Suffering from asthma or chronic lung disease requires long-term medication or oxygen therapy 7. suffering from mental illness, the clinical judgment of the host will affect the participation of the trial, such as dementia 8. Unable to comply with the test plan 9. Any other acute or chronic medical/physiological condition identified by the moderator as affecting the test results
References
Publications (0)
Data not yet available