PainNCT01718821
Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
An observational study of Pain and Neuropathic Pain, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Neuropathic Pain, Depression
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2012to Sep 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Admitted patients or out patients in National Cheng Kung University Hospital (a medical center)
Who may be able to join
- with a diagnose of advanced upper GI cancer based on pathology or imaging studies
- could report pain intensities and answer questionnaires by him/herself
Who cannot join
- with major neurologic or psychiatric diseases
- could not report pain intensities and answer questionnaires by him/herself
Trial locations and contacts
1 site in 1 country.
About this study
Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain can be well controlled in the vast majority of patients if the algorithms of pain control are systematically applied, carefully monitored, and tailored to the needs of the individual patient.This study is aimed to assess the current pain managements in upper gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled patients would also be assessed.
- Conditions
- Pain, Neuropathic Pain, Depression, Quality of Life, Upper GI Cancer
- Medical subject headings
- Pain, Neuralgia, Depression, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced upper GI cancer patients | Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, assessed by BPI-SF.
Pain intensities of participants would be assessed by BPI-SF at D1.
Measured: Assessed at enrolled date (Day 1)
Changes in pain, assessed by BPI-SF.
Changes in pain intensities of participants would be assessed by BPI-SF. The changes in pain would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
Measured: Baseline and 1 month.
Secondary outcomes (6)
Depression, assessed by two stem questions.
Depression of participants would be assessed by questionnaires as mentioned at D1.
Measured: Assessed at enrolled date (Day 1)
Changes in depression, assessed by two stem questions.
Changes in depression status would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
Measured: Baseline and 1 month.
Quality of life, assessed by EROTC QLQ C30.
Quality of life of participants would be assessed by questionnaires as mentioned at D1.
Measured: Day 1
Neuropathic pain, assessed by DN4 questions.
Neuropathic pain of participants would be assessed by questionnaires as mentioned at D1.
Measured: Day 1
Changes in quality of life. Quality of life, assessed by EROTC QLQ C30.
Changes in quality of life would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
Measured: Baseline and 1 month.
Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions.
Changes in neuropathic pain would be assessed by questionnaires as mentioned. The changes would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
Measured: Baseline and 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsu-chih Chien, National Cheng Kung University
- Investigators
- Yea-huei Kao Yang, Principal investigator, Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718821
- Sponsor's protocol ID
- A-ER-101-134
- Status last verified
- Sep 2014
- First submitted
- 16 Oct 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessments on Current Pain Managements in Upper Gastrointestinal Cancer Patients
- ClinicalTrials.gov ID
- NCT01718821
- Acronym / sponsor ID
- A-ER-101-134
- Conditions
- Pain, Neuropathic Pain, Depression, Quality of Life, Upper GI Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Oct 2012 (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.
Pain is one of the most common symptoms associated with cancer. The approach to pain management compresses routine pain assessments, utilizes both pharmacologic and nonpharmacologic interventions, and requires ongoing reevaluation of the patient. Cancer pain can be well controlled in the vast majority of patients if the algorithms of pain control are systematically applied, carefully monitored, and tailored to the needs of the individual patient.This study is aimed to assess the current pain managements in upper gastrointestinal cancer patients in Taiwan. The effects of neuropathic pain and depression on the enrolled patients would also be assessed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced upper GI cancer patients | – | –Upper GI cancers include: esophageal cancer, gastric cancer, ampulla vater cancer, pancreatic cancer and cholangiocarcinoma. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Admitted patients or out patients in National Cheng Kung University Hospital (a medical center)
Key inclusion criteria (2 listed)
- with a diagnose of advanced upper GI cancer based on pathology or imaging studies
- could report pain intensities and answer questionnaires by him/herself
Key exclusion criteria (2 listed)
- with major neurologic or psychiatric diseases
- could not report pain intensities and answer questionnaires by him/herself
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain, assessed by BPI-SF.
Time frame: Assessed at enrolled date (Day 1)
Pain intensities of participants would be assessed by BPI-SF at D1.
Changes in pain, assessed by BPI-SF.
Time frame: Baseline and 1 month.
Changes in pain intensities of participants would be assessed by BPI-SF. The changes in pain would be assessed again after 1 month when participants have outpatient visits or during their admission. An expected following duration average of would be 4 weeks.
6 secondary outcomes
Depression, assessed by two stem questions.
Time frame: Assessed at enrolled date (Day 1)
Changes in depression, assessed by two stem questions.
Time frame: Baseline and 1 month.
Quality of life, assessed by EROTC QLQ C30.
Time frame: Day 1
Neuropathic pain, assessed by DN4 questions.
Time frame: Day 1
Changes in quality of life. Quality of life, assessed by EROTC QLQ C30.
Time frame: Baseline and 1 month.
Changes in neuropathic pain. Neuropathic pain, assessed by DN4 questions.
Time frame: Baseline and 1 month.
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 25 Sep 2014.
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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.
Yea-huei Kao Yang principal investigator
Institute of Clinical Pharmacy and Pharmaceutical Science, National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Neuropathic Pain, run by National Cheng Kung University at 1 site in Taiwan.
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 2 inclusion and 2 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 25 Sep 2014. 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 Taiwan. 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.
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?
Pain, assessed by BPI-SF. (time frame: Assessed at enrolled date (Day 1)). The study lists 2 primary outcomes in all. 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 25 Sep 2014.