Human Physiology and Self-Reported Pain Score

NCT04053608 | Unknown DMC

• 1 other identifier: SF19052B
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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

Cancer Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  30days

Secondary Outcomes (1)

• Symptom Reporting and record of EQ-5D-3L (Quality of Life Questionnaire)

  30 days

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are moderate to severe cancer pain (digital rating scale NRS ≥ 4).

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Taiwan Mundipharma Pharmaceuticals Ltd.: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chih Cheng Wu, Master

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih Cheng Wu, Master

CONTACT

886-4-23592525; chihcheng.wu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pain medicine division, department of anesthesiology

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 12, 2019
• Study Start: August 8, 2019
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: August 14, 2019

Record last verified: 2019-08

Locations

TW (1)