Real-time Cancer Pain Assessment and Intervention

NCT01914107 | Unknown Phase 2

• 1 other identifier: GPM-ward
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignancy; Pain

Keywords

malignancy; solid tumor; cancer pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• quality of life

  change from baseline of quality of life at 6 weeks

Study Arms (2)

standard cancer pain care

EXPERIMENTAL

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

real-time monitoring and instruction of cancer pain

EXPERIMENTAL

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

Interventions

real-time monitoring and instruction of cancer pain PROCEDURE

as description in arm

Also known as: the cloud computing concept based real-time cancer pain assessment and intervetion system

real-time monitoring and instruction of cancer pain

standard cancer pain care PROCEDURE

as description in arm

Also known as: standard cancer pain care according to National Comprehensive Cancer Network adult cancer pain guideline

standard cancer pain care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (29)

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MeSH Terms

Conditions

Neoplasms; Pain; Cancer Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Zhang, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YuXiang Ma, M.D.

CONTACT

86-020-87343786; mayx@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 1, 2013
• Study Start: March 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 27, 2015

Record last verified: 2015-08

Locations

CN (1)