CancerGPMNCT03155516

Effect of Good Pain Management (GPM) Ward Program on Moderate to Severe Cancer Pain Patients

A study testing Good pain management (GPM) procedure and Current practice procedure in people with Cancer and Pain, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 3 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Cancer, Pain
What is being tested?: Good pain management (GPM) procedure and Current practice procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 3 sitesTaiwan
Study dates: 30 Aug 2016to 29 Aug 2019
Phase: Interventional
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

Who may be able to join

Females and males aged ≥ 20
Understand Chinese/Taiwanese and able to finish the questionnaire
Alert enough to respond and understand
Hospitalized for ≥ 24 hours
ECOG ≤ 2
Cancer patients with cancer-related pain

Who cannot join

Patient diagnosed with non-cancer pain or unexplained pain
Patient with moderate to severe mental disorder
Patient receiving operation or invasive procedure within 24 hours before admission

Trial locations and contacts

3 sites in 1 country.

Jaw-Yuan Wang, PhD contact

886-7-3121101 ext. 5583

jayuwa@cc.kmu.edu.tw

Wei-Chih Su, MD contact

886-7-3121101 ext. 5575

lake0126@yahoo.com.tw

Taiwan3 sites, 3 recruiting

Kaohsiung Municipal Ta-Tung Hospital
Kaohsiung City, 80145
Fang-Ming Chen, PhD, 886-7-2911101, fchen@cc.kmu.edu.tw
Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Jaw-Yuan Wang, PhD, 886-7-3121101 ext. 5583, jayuwa@cc.kmu.edu.tw
Wei-Chih Su, MD, 886-7-3121101 ext. 5575, lake0126@yahoo.com.tw
Recruiting
Kaohsiung Municipal Siaogang Hospital
Kaohsiung City, 812
Chieh-Han Chuang, MD, 886-7-8036783 ext. 3442, 0790151@kmhk.org.tw
Recruiting

Other trials in Taiwan

About this study

Official title: Evaluation of the Effect of Good Pain Management (GPM) Ward Program on Pattern of Care and Patient-Reported Outcomes of Moderate to Severe Cancer Pain Patients

This study aims to set up a standardized cancer pain ward - known as the Good Pain Management (GPM) Ward with streamlined assessment and management procedures to act as a pain management model. In particular, it will enforce regular pain assessment from and throughout hospital admission, and treatment protocols introducing the use of strong-opioids in moderate cancer pain patients, following National Cancer Care Network (NCCN) Adult Cancer Pain Guidelines. The GPM ward will be compared against current-practice controlled ward.

Read the detailed description

This is a double-arm, randomized, multi-center, current practice-controlled study. Approximately 150 cancer pain patients with collecting questionnaires admitted to an inpatient department from 3 national hospitals: Kaohsiung Medical University Hospital, Kaohsiung Municipal Ta-Tung Hospital and Kaohsiung Municipal HsiaoKang Hospital will be invited into this study. Eligible patients will be randomized to one of the following pain control wards in a 1:1 ratio.

GPM Ward: Good Pain management ward
Control Ward: Current practice-controlled ward Surveys, pain level measurements and dosage used will be collected in 48±8 hours. The pain management index (PMI) will be assessed as primary objective. The patient satisfaction, outcome questionnaire (APS-POQ) and SF-36 will be assessed in secondary objectives.

Once patient is admitted to the ward and agrees to participate in the study, the patient will be randomly and blindly assigned to either GPM ward or Control Ward. In the Control Ward, patient will receive the current practice of pain management, with less assessment procedure.

This study will investigate the benefits and effect of good pain control on patient outcomes in hospitalized cancer pain patients. The results aim to demonstrate the viability of GPM ward in daily practices and its measurable impact on the patient outcomes including patient treatment satisfaction as well as quality of life.

Primary objectives:

To assess pain management index (PMI)

Secondary objectives: (1) To assess the satisfaction of pain control during admission (2) To analyze the Patient Outcome Questionnaire (APS-POQ) (3) To analyze the SF-36 Questionnaire

Conditions: Cancer, Pain
Being tested: Good pain management (GPM) procedure, Current practice procedure
Keywords: Cancer pain, GPM, pain assessment
Medical subject headings: Neoplasms, Pain, Cancer Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Good pain management (GPM) procedureOther
In the GPM ward, a close pain assessment will be carried within 1 hour after admission. After the assessment, patient will be given analgesic treatment as needed, by acceptable route, frequency and dosage. A good titration is required in GPM ward. Patient will be close monitor his/her pain level regarding pain score. In opioid use, when patient complains patient level ≥ 4, low dose strong opioids will be introduced in patient suffering with moderate pain.
Compare with current practice, GPM ward will perform pain assessment with higher frequency for adjusting of analgesic medications if required.
Current practice procedureOther
Current practice clinical procedure for pain management

Study groups in NCT03155516
Study group	Role	What they receive
GPM Ward	Experimental	Good Pain management ward Receives: Other: Good pain management (GPM) procedure
Control Ward	Active comparator	Current practice controlled ward Receives: Other: Current practice procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain management index (PMI) assessment
The change of mean PMI score, pain-reporting rate and adequacy of pain treatment using pain management index
Measured: Up to 56 hours

Secondary outcomes (3)

Satisfaction of pain control during admission
Patient satisfaction about pain control
Measured: Up to 56 hours
Patient outcome questionnaire (APS-POQ) analysis
The analysis of APS-POQ outcome
Measured: Up to 56 hours
SF-36 Questionnaire analysis
The analysis of SF-36
Measured: Up to 24 hours in screening period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 201629 Aug 2019

First posted16 May 2017
Study start30 Aug 2016
Primary completion29 Aug 2019 (estimated)
Study completion29 Aug 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for 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 N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03155516
Sponsor's protocol ID: GPM16-TW-401
Acronym: GPM
Status last verified: May 2017
First submitted: 14 May 2017
Last updated: 16 May 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Kurita GP, Tange UB, Farholt H, Sonne NM, Stromgren AS, Ankersen L, Kristensen L, Bendixen L, Gronvold M, Petersen MA, Nordly M, Christrup L, Niemann C, Sjogren P. Pain characteristics and management of inpatients admitted to a comprehensive cancer centre: a cross-sectional study. Acta Anaesthesiol Scand. 2013 Apr;57(4):518-25. doi: 10.1111/aas.12068. Epub 2013 Jan 22.
PubMed 23336265
Sharma N, Hansen CH, O'Connor M, Thekkumpurath P, Walker J, Kleiboer A, Murray G, Espie C, Storey D, Sharpe M, Fleming L. Sleep problems in cancer patients: prevalence and association with distress and pain. Psychooncology. 2012 Sep;21(9):1003-9. doi: 10.1002/pon.2004. Epub 2011 Jul 1.
PubMed 21726015
American Society of Anesthesiologists Task Force on Chronic Pain Management; American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010 Apr;112(4):810-33. doi: 10.1097/ALN.0b013e3181c43103. No abstract available.
PubMed 20124882
Ripamonti CI, Bandieri E, Roila F; ESMO Guidelines Working Group. Management of cancer pain: ESMO Clinical Practice Guidelines. Ann Oncol. 2011 Sep;22 Suppl 6:vi69-77. doi: 10.1093/annonc/mdr390. No abstract available.
PubMed 21908508
National Comprehensive Cancer Network. Adult cacner pain
Tang ST, Tang WR, Liu TW, Lin CP, Chen JS. What really matters in pain management for terminally ill cancer patients in Taiwan. J Palliat Care. 2010 Autumn;26(3):151-8.
PubMed 21047037
Liang SY, Li CC, Wu SF, Wang TJ, Tsay SL. The prevalence and impact of pain among Taiwanese oncology outpatients. Pain Manag Nurs. 2011 Dec;12(4):197-205. doi: 10.1016/j.pmn.2010.10.034. Epub 2011 Jan 28.
PubMed 22117751
Seya MJ, Gelders SF, Achara OU, Milani B, Scholten WK. A first comparison between the consumption of and the need for opioid analgesics at country, regional, and global levels. J Pain Palliat Care Pharmacother. 2011;25(1):6-18. doi: 10.3109/15360288.2010.536307.
PubMed 21426212
Duthey B, Scholten W. Adequacy of opioid analgesic consumption at country, global, and regional levels in 2010, its relationship with development level, and changes compared with 2006. J Pain Symptom Manage. 2014 Feb;47(2):283-97. doi: 10.1016/j.jpainsymman.2013.03.015. Epub 2013 Jul 17.
PubMed 23870413
Pan HH, Ho ST, Lu CC, Wang JO, Lin TC, Wang KY. Trends in the consumption of opioid analgesics in Taiwan from 2002 to 2007: a population-based study. J Pain Symptom Manage. 2013 Feb;45(2):272-8. doi: 10.1016/j.jpainsymman.2012.02.014. Epub 2012 Aug 11.
PubMed 22889859
Wang CH, Lee SY. Undertreatment of caner pain. Acta Anaesthesiol Taiwan. 2015 Jun;53(2):58-61. doi: 10.1016/j.aat.2015.05.005. Epub 2015 Jun 7.
PubMed 26063333
Su WC, Chuang CH, Chen FM, Tsai HL, Huang CW, Chang TK, Hou MF, Wang JY. Effects of Good Pain Management (GPM) ward program on patterns of care and pain control in patients with cancer pain in Taiwan. Support Care Cancer. 2021 Apr;29(4):1903-1911. doi: 10.1007/s00520-020-05656-x. Epub 2020 Aug 15.
PubMed 32803728

Want to know more?

Jaw-Yuan Wang, PhD

886-7-3121101 ext. 5583

jayuwa@cc.kmu.edu.tw

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Good Pain Management (GPM) Ward Program on Pattern of Care and Patient-Reported Outcomes of Moderate to Severe Cancer Pain Patients
ClinicalTrials.gov ID: NCT03155516
Acronym / sponsor ID: GPM / GPM16-TW-401
Conditions: Cancer, Pain
Keywords: Cancer pain, GPM, pain assessment
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: Taiwan Mundipharma Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
Study start: 30 Aug 2016 (actual)
Primary completion: 29 Aug 2019 (estimated)
Study completion: 29 Aug 2019 (estimated)
First posted: 16 May 2017 (actual)
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.

Detailed description

GPM Ward: Good Pain management ward
Control Ward: Current practice-controlled ward Surveys, pain level measurements and dosage used will be collected in 48±8 hours. The pain management index (PMI) will be assessed as primary objective. The patient satisfaction, outcome questionnaire (APS-POQ) and SF-36 will be assessed in secondary objectives.

Primary objectives:

To assess pain management index (PMI)

Secondary objectives: (1) To assess the satisfaction of pain control during admission (2) To analyze the Patient Outcome Questionnaire (APS-POQ) (3) To analyze the SF-36 Questionnaire

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
GPM Ward	Experimental	Other: Good pain management (GPM) procedureGood Pain management ward
Control Ward	Active comparator	Other: Current practice procedureCurrent practice controlled ward

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Females and males aged ≥ 20
Understand Chinese/Taiwanese and able to finish the questionnaire
Alert enough to respond and understand
Hospitalized for ≥ 24 hours
ECOG ≤ 2

Key exclusion criteria (3 listed)

Patient diagnosed with non-cancer pain or unexplained pain
Patient with moderate to severe mental disorder
Patient receiving operation or invasive procedure within 24 hours before admission

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
Good pain management (GPM) procedureIn the GPM ward, a close pain assessment will be carried within 1 hour after admission. After the assessment, patient will be given analgesic treatment as needed, by acceptable route, frequency and dosage. A good titration is required in GPM ward. Patient will be close monitor his/her pain level regarding pain score. In opioid use, when patient complains patient level ≥ 4, low dose strong opioids will be introduced in patient suffering with moderate pain. Compare with current practice, GPM ward will perform pain assessment with higher frequency for adjusting of analgesic medications if required.	Other	GPM Ward
Current practice procedureCurrent practice clinical procedure for pain management	Other	Control Ward

Primary outcome

Pain management index (PMI) assessment
Time frame: Up to 56 hours
The change of mean PMI score, pain-reporting rate and adequacy of pain treatment using pain management index

3 secondary outcomes

Satisfaction of pain control during admission
Time frame: Up to 56 hours
Patient outcome questionnaire (APS-POQ) analysis
Time frame: Up to 56 hours
SF-36 Questionnaire analysis
Time frame: Up to 24 hours in screening period

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Background: PubMed 23336265Kurita GP, Tange UB, Farholt H, Sonne NM, Stromgren AS, Ankersen L, Kristensen L, Bendixen L, Gronvold M, Petersen MA, Nordly M, Christrup L, Niemann C, Sjogren P. Pain characteristics and management of inpatients admitted to a comprehensive cancer centre: a cross-sectional study. Acta Anaesthesiol Scand. 2013 Apr;57(4):518-25. doi: 10.1111/aas.12068. Epub 2013 Jan 22.
Background: PubMed 21726015Sharma N, Hansen CH, O'Connor M, Thekkumpurath P, Walker J, Kleiboer A, Murray G, Espie C, Storey D, Sharpe M, Fleming L. Sleep problems in cancer patients: prevalence and association with distress and pain. Psychooncology. 2012 Sep;21(9):1003-9. doi: 10.1002/pon.2004. Epub 2011 Jul 1.
Background: PubMed 20124882American Society of Anesthesiologists Task Force on Chronic Pain Management; American Society of Regional Anesthesia and Pain Medicine. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. 2010 Apr;112(4):810-33. doi: 10.1097/ALN.0b013e3181c43103. No abstract available.
Background: PubMed 21908508Ripamonti CI, Bandieri E, Roila F; ESMO Guidelines Working Group. Management of cancer pain: ESMO Clinical Practice Guidelines. Ann Oncol. 2011 Sep;22 Suppl 6:vi69-77. doi: 10.1093/annonc/mdr390. No abstract available.
BackgroundNational Comprehensive Cancer Network. Adult cacner pain
Background: PubMed 21047037Tang ST, Tang WR, Liu TW, Lin CP, Chen JS. What really matters in pain management for terminally ill cancer patients in Taiwan. J Palliat Care. 2010 Autumn;26(3):151-8.
Background: PubMed 22117751Liang SY, Li CC, Wu SF, Wang TJ, Tsay SL. The prevalence and impact of pain among Taiwanese oncology outpatients. Pain Manag Nurs. 2011 Dec;12(4):197-205. doi: 10.1016/j.pmn.2010.10.034. Epub 2011 Jan 28.
Background: PubMed 21426212Seya MJ, Gelders SF, Achara OU, Milani B, Scholten WK. A first comparison between the consumption of and the need for opioid analgesics at country, regional, and global levels. J Pain Palliat Care Pharmacother. 2011;25(1):6-18. doi: 10.3109/15360288.2010.536307.
Background: PubMed 23870413Duthey B, Scholten W. Adequacy of opioid analgesic consumption at country, global, and regional levels in 2010, its relationship with development level, and changes compared with 2006. J Pain Symptom Manage. 2014 Feb;47(2):283-97. doi: 10.1016/j.jpainsymman.2013.03.015. Epub 2013 Jul 17.
Background: PubMed 22889859Pan HH, Ho ST, Lu CC, Wang JO, Lin TC, Wang KY. Trends in the consumption of opioid analgesics in Taiwan from 2002 to 2007: a population-based study. J Pain Symptom Manage. 2013 Feb;45(2):272-8. doi: 10.1016/j.jpainsymman.2012.02.014. Epub 2012 Aug 11.
Background: PubMed 26063333Wang CH, Lee SY. Undertreatment of caner pain. Acta Anaesthesiol Taiwan. 2015 Jun;53(2):58-61. doi: 10.1016/j.aat.2015.05.005. Epub 2015 Jun 7.
Derived from this study: PubMed 32803728Su WC, Chuang CH, Chen FM, Tsai HL, Huang CW, Chang TK, Hou MF, Wang JY. Effects of Good Pain Management (GPM) ward program on patterns of care and pain control in patients with cancer pain in Taiwan. Support Care Cancer. 2021 Apr;29(4):1903-1911. doi: 10.1007/s00520-020-05656-x. Epub 2020 Aug 15.
Individual participant dataSharing planned: Undecided

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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.

Jaw-Yuan Wang, PhD contact

886-7-3121101 ext. 5583

jayuwa@cc.kmu.edu.tw

Wei-Chih Su, MD contact

886-7-3121101 ext. 5575

lake0126@yahoo.com.tw

Jaw-Yuan Wang, PhD principal investigator

Kaohsiung Medical University Chung-Ho Memorial Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Good pain management (GPM) procedure and Current practice procedure in people with Cancer and Pain, run by Taiwan Mundipharma Pharmaceuticals Ltd. at 3 sites 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jaw-Yuan Wang, PhD (886-7-3121101 ext. 5583, jayuwa@cc.kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain management index (PMI) assessment (time frame: Up to 56 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155516, which also lists 12 linked publications.

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 16 May 2017.