Lung Cancer
Conditions
Keywords
Lung cancer, Cancer pain, Opioid
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
Interventions
BEHAVIORALActive pain management
Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.
Sponsors
Janssen Korea, Ltd., Korea
Chonnam National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent of pain intensity difference | 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
| Measure | Time frame | Description |
|---|---|---|
| Patients' satisfaction score about pain management | visit 3 (6 to 8 weeks) | Qustionnaire of 5-point scale |
| Eastern Cooperative Oncology Group (ECOG) Performance score | visit 3 (6 to 8 weeks) | ECOG performance status: 0,1,2,3,4 |
| Assessment of Korean Brief Pain Inventory score | visit 3 (6 to 8 weeks) | Qustionnaire; K-BPI(Korean Brief Pain Inventory) |
| Investigator's global assessment score | visit 3 (6 to 8 weeks) | Qustionnaire of 5-point scale |
Countries
South Korea
Outcome results
None listed