The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study
Primary Purpose
Cancers, Pain
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cancer pain management
Sponsored by
About this trial
This is an interventional supportive care trial for Cancers, Pain focused on measuring cancer pain, opioid, guideline
Eligibility 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
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain control
Arm Description
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.
Outcomes
Primary Outcome Measures
Reduction in pain scores
Secondary Outcome Measures
Full Information
NCT ID
NCT01043068
First Posted
January 5, 2010
Last Updated
April 25, 2012
Sponsor
National Cancer Center, Korea
Collaborators
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT01043068
Brief Title
The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study
Official Title
A Pilot Study: The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
Collaborators
Janssen Korea, Ltd., Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancers, Pain
Keywords
cancer pain, opioid, guideline
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cancer pain management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in pain scores
Time Frame
Jan 2010 - October 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hyun Kim, Prof
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Effect of Cancer Pain Management Protocol on Hospitalized Cancer Patients: A Pilot Study
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