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Completed

NCT Number: NCT02765269

Intelligent Pain Management System for Assessing Pain in Cancer Patients

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.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Translational Institute for Cancer Pain, Shanghai

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intelligent Pain Management System

Device

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

Primary outcomes

  1. 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 outcomes

  1. 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. Users' Satisfaction (Questionnaire)

    Time frame: 2 weeks

    Patients will be asked to complete a questionnaire after patients use it for 2 weeks.

  3. 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.

Sponsors and collaborators

Lead sponsor

Xinhua Translational Institute for Cancer Pain, Shanghai

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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