Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)

This study is currently recruiting participants.
Verified on January 2011 by Chonnam National University Hospital

First Received on February 1, 2011.  
Last Updated on March 7, 2011  
History of Changes
This Clinical Trial Sponsored By: Chonnam National University Hospital
Collaborator: Janssen Korea, Ltd., Korea
Information provided by: Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01310387
 

Purpose for Clinical Trial

This study is:

  • A single-center, randomized, prospective controlled trial.
  • To prove superiority of active pain management group compared to control group by the percent of pain intensity difference of outpatients with lung cancer pain.
  • 204 patients will be recruited.

Condition Study Intervention Clinical Trial Phase
Lung Cancer Behavioral: Active pain management Phase III

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)

Resource links provided by NLM:

MedlinePlus related topics:
Cancer
Lung Cancer

U.S. FDA Resources

Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures For Clinical Trial:

  • The percent of pain intensity difference [ Time Frame: visit 3 (6 to 8 weeks) ] [ Designated as safety issue: No ]

    The percent of pain intensity difference (%PID)

    %PID = (NRS of visit 1 – NRS of visit 3)/NRS of visit 1

Secondary Outcome Measures For Clinical Trial:

  • Patients’ satisfaction score about pain management [ Time Frame: visit 3 (6 to 8 weeks) ] [ Designated as safety issue: No ]
    Qustionnaire of 5-point scale

  • Eastern Cooperative Oncology Group (ECOG) Performance score [ Time Frame: visit 3 (6 to 8 weeks) ] [ Designated as safety issue: No ]
    ECOG performance status: 0,1,2,3,4

  • Assessment of Korean Brief Pain Inventory score [ Time Frame: visit 3 (6 to 8 weeks) ] [ Designated as safety issue: No ]
    Qustionnaire; K-BPI(Korean Brief Pain Inventory)

  • Investigator’s global assessment score [ Time Frame: visit 3 (6 to 8 weeks) ] [ Designated as safety issue: No ]
    Qustionnaire of 5-point scale

Estimated Enrollment: 204
Study Start Date: January 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Behavioral: Active pain management

    Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.

Detailed Description:

  • The recruited patients in both group will be provided the education about pain-killer, and received medicines including opioids according to their numeric rating scale (NRS)
  • Active management group will be provided additional telephone counseling and dosage modification by specialized nurse for cancer pain.
  • The percent of pain intensity difference (%PID)

    • PID = (NRS of visit 1 – NRS of visit 3)/NRS of visit 1
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients with lung cancer.
  • The patients with uncontrolled lung cancer pain – more than and equal NRS 4 pain during previous 24 hours for background pain, or more than and equal 3 times/day for breakthrough painkiller medication.
  • Over 20 year-old male or female.
  • The patients can be able to received telephone counseling by investigator’s decision.

Exclusion Criteria:

  • Drug or alcohol abusers.
  • Child-bearing women or pregnant women.
  • The patients with moderate to severe psychiatric problems.
  • The patients who have hypersensitivity to opioids.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310387

Contacts
Contact: Young-Chul Kim, MD,PhD 82-61-379-7614 kyc0923@jnu.ac.kr
Contact: In-Jae Oh, MD,PhD 82-61-379-7617 droij@jnu.ac.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Jeonnam, Korea, Republic of
Sponsors and Collaborators
Chonnam National University Hospital
Janssen Korea, Ltd., Korea
Investigators
Study Chair: Young-Chul Kim, MD,PhD Chonnam National University Hospital
  More Information

No publications provided

Responsible Party: Young-Chul, Kim, Chonnam National University Hwasun Hospital
ClinicalTrials.gov Identifier: NCT01310387    
History of Changes
Other Study ID Numbers: PAIN_LCA_2011
Study First Received: February 1, 2011
Last Updated: March 7, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:

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