Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

• Sponsor: National Cheng Kung University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01718821
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Neuropathic Pain; Depression; Quality of Life; Upper GI Cancer

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Official Title: Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Advanced upper GI cancer patients Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.

Outcome Measures

Primary Outcome Measures

1. Pain, assessed by BPI-SF. [Assessed at enrolled date (Day 1)]

   Pain intensities of participants would be assessed by BPI-SF at D1.

2. Changes in pain, assessed by BPI-SF. [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.

Secondary Outcome Measures

1. Depression, assessed by two stem questions. [Assessed at enrolled date (Day 1)]

   Depression of participants would be assessed by questionnaires as mentioned at D1.

2. Changes in depression, assessed by two stem questions. [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.

3. Quality of life, assessed by EROTC QLQ C30. [Day 1]

   Quality of life of participants would be assessed by questionnaires as mentioned at D1.

4. Neuropathic pain, assessed by DN4 questions. [Day 1]

   Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.

5. Changes in quality of life. Quality of life, assessed by EROTC QLQ C30. [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.

6. Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hsu-chih Chien, Doctoral student, National Cheng Kung University
• ClinicalTrials.gov Identifier: NCT01718821
• Other Study ID Numbers: A-ER-101-134
• First Posted: Oct 31, 2012
• Last Update Posted: Sep 25, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Neuralgia

Study Results

No Results Posted as of Sep 25, 2014