Neoplasms, Pain
Conditions
Keywords
cancer pain, mobile applications
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.
Interventions
DEVICEIntelligent 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.
Sponsors
Xinhua Translational Institute for Cancer Pain, Shanghai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Management | 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) | 2 weeks | Patients will be asked to complete a questionnaire after patients use it for 2 weeks. |
| Karnofsky Performance Score Evaluation | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 25 |
| 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. | 21 |
| Total | 46 |
Baseline characteristics
| Characteristic | IPMS Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 15 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 6 Participants | 16 Participants |
| Gender Female | 6 Participants | 8 Participants | 14 Participants |
| Gender Male | 19 Participants | 13 Participants | 32 Participants |
| Region of Enrollment China | 25 participants | 21 participants | 46 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPMS Group | Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients | 2.37 pain assessments per day | Standard Deviation 0.53 |
Secondary
Karnofsky Performance Score Evaluation
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPMS Group | Karnofsky Performance Score Evaluation | 68.80 scores on a scale | Standard Deviation 7.23 |
| Control Group | Karnofsky Performance Score Evaluation | 56.19 scores on a scale | Standard Deviation 7.4 |
Secondary
Pain Management
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPMS Group | Pain Management | 2.20 scores on a scale | Standard Deviation 0.5 |
| Control Group | Pain Management | 2.95 scores on a scale | Standard Deviation 0.59 |
Secondary
Users' Satisfaction (Questionnaire)
Patients will be asked to complete a questionnaire after patients use it for 2 weeks.
Time frame: 2 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IPMS Group | Users' Satisfaction (Questionnaire) | very much like IPMS | 9 participants |
| IPMS Group | Users' Satisfaction (Questionnaire) | like IMPS | 16 participants |
| IPMS Group | Users' Satisfaction (Questionnaire) | dislike IPMS | 0 participants |