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

This study has been completed.
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: February 4, 2016
Last verified: February 2016
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:


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


Enrollment: 79
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active pain management
active pain management (APM) by specialized nurses for cancer pain
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   (Adult, Senior)
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
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: NCT01310387

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital
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

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: February 4, 2016
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 July 28, 2016