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


Phase 3
20 Years
80 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


- 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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

The percent of pain intensity difference

Outcome Description:

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

Outcome Time Frame:

visit 3 (6 to 8 weeks)

Safety Issue:

No

Principal Investigator

Young-Chul Kim, MD,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Chonnam National University Hospital

Authority:

Korea: Institutional Review Board

Study ID:

PAIN_LCA_2011

NCT ID:

NCT01310387

Start Date:

January 2011

Completion Date:

June 2012

Related Keywords:

  • Lung Cancer
  • Lung cancer
  • Cancer pain
  • Opioid
  • Lung Neoplasms

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