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The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01043068
First Posted: January 6, 2010
Last Update Posted: April 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea
  Purpose
The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.

Condition Intervention Phase
Cancers, Pain Drug: Cancer pain management Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients

Further study details as provided by Sang Myung Woo, National Cancer Center, Korea:

Primary Outcome Measures:
  • Reduction in pain scores [ Time Frame: Jan 2010 - October 2010 ]

Enrollment: 25
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain control
Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.
Drug: Cancer pain management
Interventions based on published pain guideline. The interventions consisted of the following: (1) nursing pain assessment of current pain, worst pain, pain relief, and acceptability of pain; (2) feedback to guide analgesic prescribing by physician.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (VAS; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment
  • A minimum age of 18 years

Exclusion Criteria:

  • Opioid intolerance
  • No longer treatment for their underlying disease.
  • Intracerebral primary or metastatic lesion
  • Impaired sensory or cognitive function
  • Pregnant or lactating woman
  • Women of child bearing potential not using a contraceptive method
  • Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
  • Any patients judged by the investigator to be unfit to participate in the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043068


Locations
Korea, Republic of
National Cancer Center
Goyang, Gyeonggi-do, Korea, Republic of, 410-769
Sponsors and Collaborators
National Cancer Center, Korea
Janssen Korea, Ltd., Korea
Investigators
Principal Investigator: Dae Hyun Kim, Prof National Cancer Center, Korea
  More Information

Responsible Party: Sang Myung Woo, MD, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01043068     History of Changes
Other Study ID Numbers: CAPAM-1
First Submitted: January 5, 2010
First Posted: January 6, 2010
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Sang Myung Woo, National Cancer Center, Korea:
cancer pain
opioid
guideline

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms