Real-time Cancer Pain Assessment and Intervention

Sun Yat-sen University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pain; Malignancy

Treatments: Procedure: standard cancer pain care; Procedure: real-time monitoring and instruction of cancer pain

Study type: Interventional

Funder types: Other

Identifiers

NCT01914107

GPM-ward

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

standard cancer pain care

Experimental group

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.

Treatment:

Procedure: standard cancer pain care

real-time monitoring and instruction of cancer pain

Experimental group

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.

Treatment:

Procedure: real-time monitoring and instruction of cancer pain