Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
Lung cancer, Cancer pain, Opioid
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Intervention
Name: Active pain management
Type: Behavioral
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Both
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.
Location
Chonnam National University Hwasun Hospital
Jeonnam, Korea, Republic of
Status: Recruiting
Start Date
January 2011
Completion Date
June 2012
Sponsors
Chonnam National University Hospital
Source
Chonnam National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page