Intelligent Pain Management System for Assessing Pain in Cancer Patients

October 23, 2016 updated by: Xinhua Translational Institute for Cancer Pain, Shanghai

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Xinhua Translational Institute for Cancer Pain, Shanghai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • IPMS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
Users' Satisfaction (Questionnaire)
Time Frame: 2 weeks
Patients will be asked to complete a questionnaire after patients use it for 2 weeks.
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Translational Institute for Cancer Pain, Shanghai

Investigators

  • Study Chair: Gang Ding, Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine, Chongming Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (ESTIMATE)

May 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 23, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XHTICP 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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