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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: August 29, 2019

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.

1. Primary objectives:

• To assess pain management index (PMI)

2. 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

Interventions

  • Other: Good pain management (GPM) procedure
    • 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.
  • Other: Current practice procedure
    • Current practice clinical procedure for pain management

Arms, Groups and Cohorts

  • Experimental: GPM Ward
    • Good Pain management ward
  • Active Comparator: Control Ward
    • Current practice controlled ward

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Females and males aged ≥ 20

2. Understand Chinese/Taiwanese and able to finish the questionnaire

3. Alert enough to respond and understand

4. Hospitalized for ≥ 24 hours

5. ECOG ≤ 2

6. Cancer patients with cancer-related pain

Exclusion Criteria

1. Patient diagnosed with non-cancer pain or unexplained pain

2. Patient with moderate to severe mental disorder

3. Patient receiving operation or invasive procedure within 24 hours before admission

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taiwan Mundipharma Pharmaceuticals Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jaw-Yuan Wang, PhD, Principal Investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Overall Contact(s)
    • Jaw-Yuan Wang, PhD, 886-7-3121101, jayuwa@cc.kmu.edu.tw

References

Kurita GP, Tange UB, Farholt H, Sonne NM, Strömgren AS, Ankersen L, Kristensen L, Bendixen L, Grønvold M, Petersen MA, Nordly M, Christrup L, Niemann C, Sjøgren 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.

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. Erratum in: Psychooncology. 2013 May;22(5):1198. Fleming, Leanne [added].

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.

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.

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.

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.

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.

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.

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.

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.

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