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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPMS group | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gang Ding | Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine, Chongming Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Translational Institute for Cancer Pain, Shanghai | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28743681 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | pain assessments per day | 2 weeks |
|
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No adverse events were assessed throughout the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gang Ding | Xinhua Translational Institute for Cancer Pain, Shanghai | 021-69691540 |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Users' Satisfaction (Questionnaire) | Patients will be asked to complete a questionnaire after patients use it for 2 weeks. | 2 weeks |
| 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. | 2 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. |
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | 2 weeks |
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| Secondary | Users' Satisfaction (Questionnaire) | Patients will be asked to complete a questionnaire after patients use it for 2 weeks. | Posted | Number | participants | 2 weeks |
|
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| 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. | Posted | Mean | Standard Deviation | scores on a scale | 2 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
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| Title | Measurements |
|---|---|
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