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CompletedNCT01310387APMUpdated Feb 5, 2016

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

A Phase 3 interventional study of Active pain management in Lung Cancer, sponsored by Chonnam National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-05.

Sponsored by Chonnam National University Hospital · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
79
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

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.
Read the 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
02

Conditions studied

  • Lung Cancer

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Keywords

  • Lung cancer
  • Cancer pain
  • Opioid
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 79 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Chonnam National University Hospital is the lead sponsor of 70 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    active pain management

    active pain management (APM) by specialized nurses for cancer pain

    Behavioral: Active pain management

Interventions

  • BehavioralActive pain management

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

06

What researchers measure

Primary outcomes

  1. The percent of pain intensity difference

    The percent of pain intensity difference (%PID) %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

    Time frame: visit 3 (6 to 8 weeks)

Secondary outcomes

  1. Patients' satisfaction score about pain management

    Qustionnaire of 5-point scale

    Time frame: visit 3 (6 to 8 weeks)

  2. Eastern Cooperative Oncology Group (ECOG) Performance score

    ECOG performance status: 0,1,2,3,4

    Time frame: visit 3 (6 to 8 weeks)

  3. Assessment of Korean Brief Pain Inventory score

    Qustionnaire; K-BPI(Korean Brief Pain Inventory)

    Time frame: visit 3 (6 to 8 weeks)

  4. Investigator's global assessment score

    Qustionnaire of 5-point scale

    Time frame: visit 3 (6 to 8 weeks)

07

Study locations

1 site
  • Chonnam National University Hwasun Hospital
    Jeonnam, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01310387
Lead sponsor
Chonnam National University Hospital
Collaborators
Janssen Korea, Ltd., Korea
Responsible party
Young-Chul Kim (Professor, Chonnam National University Hospital) — Principal investigator
First posted
Mar 8, 2011
Start date
Jan 2011
Primary completion
Jan 2012
Completion
Jun 2012
Last update
Feb 5, 2016

Study contacts

Young-Chul Kim, MD,PhD
study chair · Chonnam National University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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