Real-time Cancer Pain Assessment and Intervention

August 26, 2015 updated by: Li Zhang, Sun Yat-sen University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard cancer pain care
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
as description in arm
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

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
as description in arm
Other Names:
  • the cloud computing concept based real-time cancer pain assessment and intervetion system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: up to 9 weeks

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
Time Frame: up to 9 weeks

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
Time Frame: change from baseline of quality of life at 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

August 1, 2013

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPM-ward

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on standard cancer pain care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe