Lung CancerPhase 3APMNCT01310387
Prospective Study of Active Pain Management in Lung Cancer Outpatients (APM)
A Phase 3 study testing Active pain management in people with Lung Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Active pain management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)
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.
Read the 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
- Being tested
- Active pain management
- Keywords
- Lung cancer, Cancer pain, Opioid
- Medical subject headings
- Lung Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active pain managementBehavioural
Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.
| Study group | Role | What they receive |
|---|---|---|
| active pain management | Experimental | active pain management (APM) by specialized nurses for cancer pain Receives: Behavioral: Active pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: visit 3 (6 to 8 weeks)
Secondary outcomes (4)
Patients' satisfaction score about pain management
Qustionnaire of 5-point scale
Measured: visit 3 (6 to 8 weeks)
Eastern Cooperative Oncology Group (ECOG) Performance score
ECOG performance status: 0,1,2,3,4
Measured: visit 3 (6 to 8 weeks)
Assessment of Korean Brief Pain Inventory score
Qustionnaire; K-BPI(Korean Brief Pain Inventory)
Measured: visit 3 (6 to 8 weeks)
Investigator's global assessment score
Qustionnaire of 5-point scale
Measured: visit 3 (6 to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Principal investigator, Young-Chul Kim, Chonnam National University Hospital
- Investigators
- Young-Chul Kim, MD,PhD, Study chair, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310387
- Sponsor's protocol ID
- PAIN_LCA_2011
- Acronym
- APM
- Status last verified
- Feb 2016
- First submitted
- 1 Feb 2011
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Controlled Study of Active Pain Management in Lung Cancer Outpatients (APM)
- ClinicalTrials.gov ID
- NCT01310387
- Acronym / sponsor ID
- APM / PAIN_LCA_2011
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Cancer pain, Opioid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active pain management | Experimental | Behavioral: Active pain managementactive pain management (APM) by specialized nurses for cancer pain |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active pain managementActive pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification. | Behavioural | active pain management |
Primary outcome
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
4 secondary outcomes
Patients' satisfaction score about pain management
Time frame: visit 3 (6 to 8 weeks)
Eastern Cooperative Oncology Group (ECOG) Performance score
Time frame: visit 3 (6 to 8 weeks)
Assessment of Korean Brief Pain Inventory score
Time frame: visit 3 (6 to 8 weeks)
Investigator's global assessment score
Time frame: visit 3 (6 to 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Chul Kim, MD,PhD study chair
Chonnam National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active pain management in people with Lung Cancer, run by Chonnam National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent of pain intensity difference (time frame: visit 3 (6 to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.