Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

NCT01718821 | Completed

• 1 other identifier: A-ER-101-134
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Neuropathic Pain; Depression; Quality of Life; Upper GI Cancer

Outcome Measures

Primary Outcomes (2)

• Pain, assessed by BPI-SF.

  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.

  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 Outcomes (6)

• Depression, assessed by two stem questions.

  Assessed at enrolled date (Day 1)

• Changes in depression, assessed by two stem questions.

  Baseline and 1 month.

• Quality of life, assessed by EROTC QLQ C30.

  Day 1

• Neuropathic pain, assessed by DN4 questions.

  Day 1

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

  Baseline and 1 month.

Study Arms (1)

Advanced upper GI cancer patients

Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• with a diagnose of advanced upper GI cancer based on pathology or imaging studies
• could report pain intensities and answer questionnaires by him/herself

You may not qualify if:

• with major neurologic or psychiatric diseases
• could not report pain intensities and answer questionnaires by him/herself

Sponsors & Collaborators

• National Cheng Kung University: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Pain; Neuralgia; Depression; Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Yea-huei Kao Yang

  Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral student

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 31, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

TW (1)