Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hsu-chih Chien, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT01718821
First received: October 16, 2012
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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.


Condition
Pain
Neuropathic Pain
Depression
Quality of Life
Upper GI Cancer

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cheng Kung University:

Primary Outcome Measures:
  • Pain, assessed by BPI-SF. [ Time Frame: Assessed at enrolled date (Day 1) ] [ Designated as safety issue: No ]
    Pain intensities of participants would be assessed by BPI-SF at D1.

  • Changes in pain, assessed by BPI-SF. [ Time Frame: Baseline and 1 month. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Depression, assessed by two stem questions. [ Time Frame: Assessed at enrolled date (Day 1) ] [ Designated as safety issue: No ]
    Depression of participants would be assessed by questionnaires as mentioned at D1.

  • Changes in depression, assessed by two stem questions. [ Time Frame: Baseline and 1 month. ] [ Designated as safety issue: No ]
    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.

  • Quality of life, assessed by EROTC QLQ C30. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Quality of life of participants would be assessed by questionnaires as mentioned at D1.

  • Neuropathic pain, assessed by DN4 questions. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.

  • Changes in quality of life. Quality of life, assessed by EROTC QLQ C30. [ Time Frame: Baseline and 1 month. ] [ Designated as safety issue: No ]
    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.

  • Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions. [ Time Frame: Baseline and 1 month. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 250
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advanced upper GI cancer patients
Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718821

Locations
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 701
Sponsors and Collaborators
National Cheng Kung University
Investigators
Principal Investigator: Yea-huei Kao Yang Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University
  More Information

No publications provided

Responsible Party: Hsu-chih Chien, Doctoral student, National Cheng Kung University
ClinicalTrials.gov Identifier: NCT01718821     History of Changes
Other Study ID Numbers: A-ER-101-134
Study First Received: October 16, 2012
Last Updated: September 11, 2013
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Depression
Depressive Disorder
Neuralgia
Gastrointestinal Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014