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
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 April 17, 2014