Real-time Cancer Pain Assessment and Intervention

Pain Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914107
• Other study ID #: GPM-ward
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 29, 2013
• Last updated: August 26, 2015
• Start date: March 2012
• Est. completion date: June 2018

Study information

• Verified date: August 2015
• Source: Sun Yat-sen University
• Contact: YuXiang Ma, M.D.
• Phone: 86-020-87343786
• Email: mayx[@]sysucc.org.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Malignancy
• Pain

Intervention

Procedure:
• real-time monitoring and instruction of cancer pain
as description in arm
• standard cancer pain care
as description in arm

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No