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

NCT03155516 | Unknown

• 1 other identifier: GPM16-TW-401
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cancer; Pain

Keywords

Cancer pain; GPM; pain assessment

Outcome Measures

Primary Outcomes (1)

• Pain management index (PMI) assessment

  The change of mean PMI score, pain-reporting rate and adequacy of pain treatment using pain management index

  Up to 56 hours

Secondary Outcomes (3)

• Satisfaction of pain control during admission

  Up to 56 hours

• Patient outcome questionnaire (APS-POQ) analysis

  Up to 56 hours

• SF-36 Questionnaire analysis

  Up to 24 hours in screening period

Study Arms (2)

GPM Ward

EXPERIMENTAL

Good Pain management ward

Other: Good pain management (GPM) procedure

Control Ward

ACTIVE COMPARATOR

Current practice controlled ward

Other: Current practice procedure

Interventions

Good pain management (GPM) procedure OTHER

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.

GPM Ward

Current practice procedure OTHER

Current practice clinical procedure for pain management

Control Ward

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiwan Mundipharma Pharmaceuticals Ltd.: lead

Study Sites (3)

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, 80145, Taiwan

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Kaohsiung Municipal Siaogang Hospital

Kaohsiung City, 812, Taiwan

RECRUITING

Related Publications (12)

• 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.

  PMID: 23336265 BACKGROUND

• 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.

  PMID: 21726015 BACKGROUND

• 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.

  PMID: 20124882 BACKGROUND

• 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.

  PMID: 21908508 BACKGROUND

• National Comprehensive Cancer Network. Adult cacner pain

  BACKGROUND

• 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.

  PMID: 21047037 BACKGROUND

• 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.

  PMID: 22117751 BACKGROUND

• 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.

  PMID: 21426212 BACKGROUND

• 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.

  PMID: 23870413 BACKGROUND

• 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.

  PMID: 22889859 BACKGROUND

• 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.

  PMID: 26063333 BACKGROUND

• 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.

  PMID: 32803728 DERIVED

MeSH Terms

Conditions

Neoplasms; Pain; Cancer Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaw-Yuan Wang, PhD

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaw-Yuan Wang, PhD

CONTACT

886-7-3121101; jayuwa@cc.kmu.edu.tw

Wei-Chih Su, MD

CONTACT

886-7-3121101; lake0126@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 16, 2017
• Study Start: August 30, 2016
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

TW (3)