A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- The percent of pain intensity difference
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
active pain management
active pain management (APM) by specialized nurses for cancer pain
Intervention: Active pain management (Behavioral)
Outcomes
Primary Outcomes
The percent of pain intensity difference
Time Frame: visit 3 (6 to 8 weeks)
The percent of pain intensity difference (%PID) %PID = (NRS of visit 1 - NRS of visit 3)/NRS of visit 1
Secondary Outcomes
- Assessment of Korean Brief Pain Inventory score(visit 3 (6 to 8 weeks))
- Patients' satisfaction score about pain management(visit 3 (6 to 8 weeks))
- Eastern Cooperative Oncology Group (ECOG) Performance score(visit 3 (6 to 8 weeks))
- Investigator's global assessment score(visit 3 (6 to 8 weeks))
Investigators
Young-Chul Kim
Professor
Chonnam National University Hospital