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Trial record 28 of 77033 for:    Neoplasms

Real-time Cancer Pain Assessment and Intervention

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ClinicalTrials.gov Identifier: NCT01914107
Recruitment Status : Unknown
Verified August 2015 by Li Zhang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : August 1, 2013
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Malignancy Pain Procedure: real-time monitoring and instruction of cancer pain Procedure: standard cancer pain care Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : March 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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 Name: 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 Name: the cloud computing concept based real-time cancer pain assessment and intervetion system




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914107


Contacts
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Contact: YuXiang Ma, M.D. 86-020-87343786 mayx@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yuxiang Ma, M.D.    86-020-87343894    mayx@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Li Zhang, professor Sun Yat-sen University

Publications:

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Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01914107     History of Changes
Other Study ID Numbers: GPM-ward
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015

Keywords provided by Li Zhang, Sun Yat-sen University:
malignancy
solid tumor
cancer pain

Additional relevant MeSH terms:
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Neoplasms
Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms