Real-time Cancer Pain Assessment and Intervention

NCT ID: NCT01914107

Last Updated: 2015-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-06-30

Brief Summary

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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

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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.

Conditions

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Malignancy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

standard cancer pain care

Intervention Type PROCEDURE

as description in arm

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.

Group Type EXPERIMENTAL

real-time monitoring and instruction of cancer pain

Intervention Type PROCEDURE

as description in arm

Interventions

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real-time monitoring and instruction of cancer pain

as description in arm

Intervention Type PROCEDURE

standard cancer pain care

as description in arm

Intervention Type PROCEDURE

Other Intervention Names

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the cloud computing concept based real-time cancer pain assessment and intervetion system standard cancer pain care according to National Comprehensive Cancer Network adult cancer pain guideline

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Zhang, professor

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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YuXiang Ma, M.D.

Role: CONTACT

86-020-87343786

Facility Contacts

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Yuxiang Ma, M.D.

Role: primary

86-020-87343894

References

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Other Identifiers

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GPM-ward

Identifier Type: -

Identifier Source: org_study_id

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