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

NCT ID: NCT01310387

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-06-30

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

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

active pain management

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

Group Type: EXPERIMENTAL

Active pain management

Intervention Type: BEHAVIORAL

Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.

Interventions

Active pain management

Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Young-Chul Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Young-Chul Kim, MD,PhD

Role: STUDY_CHAIR

Chonnam National University Hospital

Locations

Chonnam National University Hwasun Hospital

Jeonnam, , South Korea

Countries

South Korea

Other Identifiers

PAIN_LCA_2011

Identifier Type: -

Identifier Source: org_study_id