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

Lung Cancer Clinical Trial

— APM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310387
• Other study ID #: PAIN_LCA_2011
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2011
• Last updated: February 4, 2016
• Start date: January 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2016
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeonnam

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Patients' satisfaction score about pain management	Qustionnaire of 5-point scale	visit 3 (6 to 8 weeks)	No
Secondary	Eastern Cooperative Oncology Group (ECOG) Performance score	ECOG performance status: 0,1,2,3,4	visit 3 (6 to 8 weeks)	No
Secondary	Assessment of Korean Brief Pain Inventory score	Qustionnaire; K-BPI(Korean Brief Pain Inventory)	visit 3 (6 to 8 weeks)	No
Secondary	Investigator's global assessment score	Qustionnaire of 5-point scale	visit 3 (6 to 8 weeks)	No