Real-time Cancer Pain Assessment and Intervention

Study Overview
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Brief Summary
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This study aim at the advanced malignant tumor patients who suffer from cancer pain, investigate the current status of cancer pain treatment, and study the effects in pain control and quality of life improvement using the method of real-time monitoring and treatment instruction of cancer pain. This study is a randomized, controlled, single center clinical study. After recruitment, the subjects will randomly assign to standard cancer pain treatment group and standard cancer pain treatment plus real-time dynamic monitoring and treatment intervention of cancer pain using the cloud computing concept system. And then, assess the alleviation of cancer pain and quality of live. The assumption is the system will alleviate the cancer pain efficiently.

Detailed Description
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Cancer pain is a common symptom exists in malignant tumor patients, which bother the patients and decrease the quality of life. The goal of the study is that using the real-time monitoring and intervention system will alleviate cancer pain better than the standard cancer pain treatment. The cloud computing concept is developed by Sun Yat-sen University cancer center, and accord with clinical practice. The subjects receive the real-time monitoring and intervention system will install the software and report in the contents of cancer pain in the software correspondingly to the doctors, and advices will be given by the software as well. The quality of life and overall survival follow-up is also required.

Official Title
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A Randomized, Controlled Clinical Study: Assess and Intervene Cancer Pain of Advanced Malignant Tumor Patients in Real-Time, Using the Real-time Cancer Pain Assessment and Intervention System Based on Cloud Computing Concept.

Conditions
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Malignancy, Pain

Intervention / Treatment
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* Procedure: real-time monitoring and instruction of cancer pain
* Procedure: standard cancer pain care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid tumors confirmed by pathology or cytology Eastern Cooperative Oncology Group Performance Status: 0-2 sign the informed consent form good compliance, willing to comply with the requirements of the study anticipate survival time more than 3 months pain intensity is greater than 2 points according to numerical rating scale on enrollment; have indication of opioid analgesic drugs. can express subjective feelings of pain intensity clearly. own a smartphone or tablet device which can install and use the application program software, and can operate the software proficiently. Exclusion Criteria: poor compliance, refuse to sign the informed consent form, or difficult to comply with the requirement of the study. slight pain or no pain, no indication of opioid analgesic drugs. contraindication of opioid analgesic drugs no other medical workers give instructions during the study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: standard cancer pain care<br>the standard cancer pain care group: 1.will be follow-up by the cancer nurse once a week to acknowledge the cancer pain intensity, the current analgesic medication, and the side effects. and also give recommendations. 2.filled in the patient'diary and hand over to researchers. | Procedure: standard cancer pain care<br>* as description in arm<br>* Other names: standard cancer pain care according to National Comprehensive Cancer Network adult cancer pain guideline;|
| Experimental: real-time monitoring and instruction of cancer pain<br>real-time monitoring and treatment instruction of cancer pain group 1.follow the same pattern of standard cancer pain care. 2. using the cloud computing concept system, install the software in the mobile phone of patients. the patients will fill in the content of brief pain inventory, medication and side effect, and upload to researchers every 2 days. 3. Researcher monitor the cancer pain treatment in realtime and give instructions. | Procedure: real-time monitoring and instruction of cancer pain<br>* as description in arm<br>* Other names: the cloud computing concept based real-time cancer pain assessment and intervetion system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | the numeric rating scale and visual analogue scale of pain during the chemotherapy. using brief pain inventory scales. in this case, once 2 days in intervention group; once a weeks in control group; and a comprehensive cancer pain assessment according to national comprehensive cancer network adult pain guidance every cycle. within 3 weeks after withdraw, all of the statistics will be analyzed. | up to 9 weeks | 
| duration of pain | the numeric rating scale and visual analogue scale of pain during the chemotherapy. using brief pain inventory scales. in this case, once 2 days in intervention group; once a weeks in control group; and a comprehensive cancer pain assessment according to national comprehensive cancer network adult pain guidance every cycle. within 3 weeks after withdraw, all of the statistics will be analyzed. | up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | the quality of life assessment will be conducted before the chemotherapy, after 1st cycle chemotherapy, and after 2nd cycle of chemotherapy. | change from baseline of quality of life at 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignancy, solid tumor, cancer pain