Clinical trial NCT01914107: Real-time Cancer Pain Assessment and Intervention
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Malignancy
Pain
Keywords: malignancy
solid tumor
cancer pain
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-08-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 1. Cancer pain is a common symptom exists in malignant tumor patients, which bother the patients and decrease the quality of life.
2. 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.
3. The cloud computing concept is developed by Sun Yat-sen University cancer center, and accord with clinical practice.
4. 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.
5. The quality of life and overall survival follow-up is also required.

Eligibility criteria: 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.

Primary outcomes:
measure: pain intensity
timeFrame: up to 9 weeks
measure: duration of pain
timeFrame: up to 9 weeks
Secondary outcomes:
measure: quality of life
timeFrame: change from baseline of quality of life at 6 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang, professor
role: PRINCIPAL_INVESTIGATOR
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