Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

September 24, 2014 updated by: Hsu-chih Chien, National Cheng Kung University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 701
        • National Cheng Kung University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Admitted patients or out patients in National Cheng Kung University Hospital (a medical center)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Advanced upper GI cancer patients
Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain, assessed by BPI-SF.
Time Frame: Assessed at enrolled date (Day 1)
Pain intensities of participants would be assessed by BPI-SF at D1.
Assessed at enrolled date (Day 1)
Changes in pain, assessed by BPI-SF.
Time Frame: Baseline and 1 month.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression, assessed by two stem questions.
Time Frame: Assessed at enrolled date (Day 1)
Depression of participants would be assessed by questionnaires as mentioned at D1.
Assessed at enrolled date (Day 1)
Changes in depression, assessed by two stem questions.
Time Frame: Baseline and 1 month.
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.
Quality of life, assessed by EROTC QLQ C30.
Time Frame: Day 1
Quality of life of participants would be assessed by questionnaires as mentioned at D1.
Day 1
Neuropathic pain, assessed by DN4 questions.
Time Frame: Day 1
Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.
Day 1
Changes in quality of life. Quality of life, assessed by EROTC QLQ C30.
Time Frame: Baseline and 1 month.
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.
Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions.
Time Frame: Baseline and 1 month.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Investigators

  • Principal Investigator: Yea-huei Kao Yang, Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 28, 2012

First Posted (Estimate)

October 31, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-101-134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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