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

This study has been completed.
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Sang Myung Woo, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01043068
First received: January 5, 2010
Last updated: April 25, 2012
Last verified: April 2012
  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: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reduction in pain scores [ Time Frame: Jan 2010 - October 2010 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sang Myung Woo, MD, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01043068     History of Changes
Other Study ID Numbers: CAPAM-1
Study First Received: January 5, 2010
Last Updated: April 25, 2012
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014