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

This study is currently recruiting participants.
Verified January 2012 by Chonnam National University Hospital
Sponsor:
Collaborator:
Janssen Korea, Ltd., Korea
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01310387
First received: February 1, 2011
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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 Intervention Phase
Lung Cancer
 Behavioral: Active pain management
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy 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:
  • 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:
  • 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)
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, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01310387     History of Changes
Other Study ID Numbers: PAIN_LCA_2011
Study First Received: February 1, 2011
Last Updated: January 10, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Chonnam National University Hospital:
Lung cancer
Cancer pain
Opioid

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013