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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Active pain management
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung cancer, Cancer pain, Opioid

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chonnam National University Hwasun Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active pain management

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 1, 2011
Last Updated
February 4, 2016
Sponsor
Chonnam National University Hospital
Collaborators
Janssen Korea, Ltd., Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01310387
Brief Title
Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)
Acronym
APM
Official Title
A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Janssen Korea, Ltd., Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, Cancer pain, Opioid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
active pain management
Arm Type
Experimental
Arm Description
active pain management (APM) by specialized nurses for cancer pain
Intervention Type
Behavioral
Intervention Name(s)
Active pain management
Intervention Description
Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.
Primary Outcome Measure Information:
Title
The percent of pain intensity difference
Description
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 Outcome Measure Information:
Title
Patients' satisfaction score about pain management
Description
Qustionnaire of 5-point scale
Time Frame
visit 3 (6 to 8 weeks)
Title
Eastern Cooperative Oncology Group (ECOG) Performance score
Description
ECOG performance status: 0,1,2,3,4
Time Frame
visit 3 (6 to 8 weeks)
Title
Assessment of Korean Brief Pain Inventory score
Description
Qustionnaire; K-BPI(Korean Brief Pain Inventory)
Time Frame
visit 3 (6 to 8 weeks)
Title
Investigator's global assessment score
Description
Qustionnaire of 5-point scale
Time Frame
visit 3 (6 to 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Chul Kim, MD,PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Jeonnam
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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