Intelligent Pain Management System for Assessing Pain in Cancer Patients

Pain Clinical Trial

Official title:

Development and Testing of an Intelligent Pain Management System (IPMS) for Chinese Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765269
• Other study ID #: XHTICP 001
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: May 29, 2016
• Start date: May 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Xinhua Translational Institute for Cancer Pain, Shanghai
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the Intelligent Pain Management System (IPMS) could make recording and interfering pain timely among cancer patients with pain. The system's usability, feasibility, compliance, and satisfaction will also be assessed.

Description:

Research indicate that over one-third of cancer patients experienced cancer pain, which is known as a major reason leading to lower quality of life of the patients.In this present study, the investigators aim to design, develop, and test the feasibility of a low cost, conveniently implemented mobile application to facilitate real-time pain recording and timely intervention among Chinese cancer patients with pain. This system evaluate real-time pain and Karnofsky Performance Status（KPS）scores for quality of life, and to generate an action plan to visit the physician or to adjust pain medication dosage when the pain threshold is reached. The investigators study is to test this system's effectiveness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• the patient was able to read Chinese and use smart phones;

• the patient was diagnosed with cancer and has self-reported cancer pain within a month prior to the study;

• the patient was being seen on a regular basis by the oncology team;

• the patient was under standard analgesia treatments;

• the patient was estimated to have over 3 months survival time.

Exclusion Criteria:

• the patients who self-reported to have severe cognitive impairments or major comorbid illnesses that would interfere with pain assessment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neoplasms
• Pain

Intervention

Device:
• Intelligent Pain Management System
A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.

Locations

Country	Name	City	State
China	Xinhua Translational Institute for Cancer Pain, Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Translational Institute for Cancer Pain, Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of mobile application assessed by observing the number of daily pain assessments recorded among patients	The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.	2 weeks	No
Secondary	Pain Management	The investigators will compare average pain score assessed by numerical rating scale.	2 weeks	No
Secondary	Users' satisfaction (questionnaire)	Patients will be asked to complete a questionnaire after patients use it for 2 weeks.	2 weeks	No
Secondary	KPS Evaluation	The investigators will compare average KPS score between trial group and control group.	2 weeks	No