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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Active pain management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active pain management<br>active pain management (APM) by specialized nurses for cancer pain | Behavioral: Active pain management<br>* Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | visit 3 (6 to 8 weeks) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Cancer pain, Opioid