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Completed

NCT Number: NCT01718821

Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients

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.

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Key information

Conditions

Pain Behavior Behavioral Symptoms Depression Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Quality of Life Signs and Symptoms Upper GI Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng Kung University Hospital

Tainan, 701, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Neuropathic pain, assessed by DN4 questions.

    Time frame: 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.

    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.

  6. 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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Oct 31, 2012
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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