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Real-time Cancer Pain Assessment and Intervention

Primary Purpose

Malignancy, Pain

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
real-time monitoring and instruction of cancer pain
standard cancer pain care
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignancy focused on measuring malignancy, solid tumor, cancer pain

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard cancer pain care

real-time monitoring and instruction of cancer pain

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

quality of life
the quality of life assessment will be conducted before the chemotherapy, after 1st cycle chemotherapy, and after 2nd cycle of chemotherapy.

Full Information

First Posted
July 29, 2013
Last Updated
August 26, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01914107
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignancy, Pain
Keywords
malignancy, solid tumor, cancer pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard cancer pain care
Arm Type
Experimental
Arm Description
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.
Arm Title
real-time monitoring and instruction of cancer pain
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
real-time monitoring and instruction of cancer pain
Other Intervention Name(s)
the cloud computing concept based real-time cancer pain assessment and intervetion system
Intervention Description
as description in arm
Intervention Type
Procedure
Intervention Name(s)
standard cancer pain care
Other Intervention Name(s)
standard cancer pain care according to National Comprehensive Cancer Network adult cancer pain guideline
Intervention Description
as description in arm
Primary Outcome Measure Information:
Title
pain intensity
Description
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.
Time Frame
up to 9 weeks
Title
duration of pain
Description
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.
Time Frame
up to 9 weeks
Secondary Outcome Measure Information:
Title
quality of life
Description
the quality of life assessment will be conducted before the chemotherapy, after 1st cycle chemotherapy, and after 2nd cycle of chemotherapy.
Time Frame
change from baseline of quality of life at 6 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YuXiang Ma, M.D.
Phone
86-020-87343786
Email
mayx@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxiang Ma, M.D.
Phone
86-020-87343894
Email
mayx@sysucc.org.cn

12. IPD Sharing Statement

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Real-time Cancer Pain Assessment and Intervention

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