Intelligent Pain Management System for Assessing Pain in Cancer Patients

Overview

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.

Full Title of Study: “Development and Testing of an Intelligent Pain Management System (IPMS) for Chinese Patients With Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2016

Detailed 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: IPMS group
    • Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.
  • No Intervention: Control group
    • The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors’ therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients
    • Time Frame: 2 weeks
    • The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.

Secondary Measures

  • Pain Management
    • Time Frame: 2 weeks
    • Numerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where “0″ means “no pain” and “10″ means pain as “bad as it could be”. Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period.
  • Users’ Satisfaction (Questionnaire)
    • Time Frame: 2 weeks
    • Patients will be asked to complete a questionnaire after patients use it for 2 weeks.
  • Karnofsky Performance Score Evaluation
    • Time Frame: 2 weeks
    • The Karnofsky performance score runs from 100 to 0, where 100 is “perfect” health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Xinhua Translational Institute for Cancer Pain, Shanghai
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gang Ding, Study Chair, Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine, Chongming Branch

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