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

Phase 3

Completed

• Conditions: Lung Cancer
• Interventions: Behavioral: Active pain management

• Registration Number: NCT01310387
• Lead Sponsor: Chonnam National University Hospital

Brief 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.

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Primary Completion: 2012-01
• Study Completion: 2012-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active pain management	Active pain management	active pain management (APM) by specialized nurses for cancer pain

Primary Outcome Measures

Name	Time	Method
The percent of pain intensity difference	visit 3 (6 to 8 weeks)	The percent of pain intensity difference (%PID); %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction score about pain management	visit 3 (6 to 8 weeks)	Qustionnaire of 5-point scale
Eastern Cooperative Oncology Group (ECOG) Performance score	visit 3 (6 to 8 weeks)	ECOG performance status: 0,1,2,3,4
Assessment of Korean Brief Pain Inventory score	visit 3 (6 to 8 weeks)	Qustionnaire; K-BPI(Korean Brief Pain Inventory)
Investigator's global assessment score	visit 3 (6 to 8 weeks)	Qustionnaire of 5-point scale

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Jeonnam, Korea, Republic of