Clinical trial NCT02765269: Intelligent Pain Management System for Assessing Pain in Cancer Patients
Official title: Development and Testing of an Intelligent Pain Management System (IPMS) for Chinese Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Neoplasms
Keywords: cancer pain
mobile applications
Lead sponsor: Xinhua Translational Institute for Cancer Pain, Shanghai
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 46
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain Management
timeFrame: 2 weeks
measure: Users' Satisfaction (Questionnaire)
timeFrame: 2 weeks
measure: Karnofsky Performance Score Evaluation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Translational Institute for Cancer Pain, Shanghai
state: Shanghai
Study officials:
affiliation: Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine, Chongming Branch
name: Gang Ding
role: STUDY_CHAIR
References:
citation: Sun Y, Jiang F, Gu JJ, Wang YK, Hua H, Li J, Cheng Z, Liao Z, Huang Q, Hu W, Ding G. Development and Testing of an Intelligent Pain Management System (IPMS) on Mobile Phones Through a Randomized Trial Among Chinese Cancer Patients: A New Approach in Cancer Pain Management. JMIR Mhealth Uhealth. 2017 Jul 25;5(7):e108. doi: 10.2196/mhealth.7178.