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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01718821
Other study ID # A-ER-101-134
Secondary ID
Status Completed
Phase N/A
First received October 16, 2012
Last updated September 24, 2014
Start date September 2012
Est. completion date September 2014

Study information

Verified date September 2014
Source National Cheng Kung University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain can be well controlled in the vast majority of patients if the algorithms of pain control are systematically applied, carefully monitored, and tailored to the needs of the individual patient.This study is aimed to assess the current pain managements in upper gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled patients would also be assessed.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- with a diagnose of advanced upper GI cancer based on pathology or imaging studies

- could report pain intensities and answer questionnaires by him/herself

Exclusion Criteria:

- with major neurologic or psychiatric diseases

- could not report pain intensities and answer questionnaires by him/herself

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Locations

Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain, assessed by BPI-SF. Pain intensities of participants would be assessed by BPI-SF at D1. Assessed at enrolled date (Day 1) No
Primary Changes in pain, assessed by BPI-SF. Changes in pain intensities of participants would be assessed by BPI-SF. The changes in pain would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks. Baseline and 1 month. No
Secondary Depression, assessed by two stem questions. Depression of participants would be assessed by questionnaires as mentioned at D1. Assessed at enrolled date (Day 1) No
Secondary Changes in depression, assessed by two stem questions. Changes in depression status would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks. Baseline and 1 month. No
Secondary Quality of life, assessed by EROTC QLQ C30. Quality of life of participants would be assessed by questionnaires as mentioned at D1. Day 1 No
Secondary Neuropathic pain, assessed by DN4 questions. Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1. Day 1 No
Secondary Changes in quality of life. Quality of life, assessed by EROTC QLQ C30. Changes in quality of life would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks. Baseline and 1 month. No
Secondary Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions. Changes in neuropathic pain would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks. Baseline and 1 month. No
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