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

Primary Purpose

Cancer, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Good pain management (GPM) procedure
Current practice procedure
Sponsored by
Taiwan Mundipharma Pharmaceuticals Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer pain, GPM, pain assessment

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Municipal Ta-Tung HospitalRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • Kaohsiung Municipal Siaogang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GPM Ward

Control Ward

Arm Description

Good Pain management ward

Current practice controlled ward

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Satisfaction of pain control during admission
Patient satisfaction about pain control
Patient outcome questionnaire (APS-POQ) analysis
The analysis of APS-POQ outcome
SF-36 Questionnaire analysis
The analysis of SF-36

Full Information

First Posted
May 14, 2017
Last Updated
May 15, 2017
Sponsor
Taiwan Mundipharma Pharmaceuticals Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03155516
Brief Title
Effect of Good Pain Management (GPM) Ward Program on Moderate to Severe Cancer Pain Patients
Acronym
GPM
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
August 29, 2019 (Anticipated)
Study Completion Date
August 29, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiwan Mundipharma Pharmaceuticals Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Pain
Keywords
Cancer pain, GPM, pain assessment

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GPM Ward
Arm Type
Experimental
Arm Description
Good Pain management ward
Arm Title
Control Ward
Arm Type
Active Comparator
Arm Description
Current practice controlled ward
Intervention Type
Other
Intervention Name(s)
Good pain management (GPM) procedure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Current practice procedure
Intervention Description
Current practice clinical procedure for pain management
Primary Outcome Measure Information:
Title
Pain management index (PMI) assessment
Description
The change of mean PMI score, pain-reporting rate and adequacy of pain treatment using pain management index
Time Frame
Up to 56 hours
Secondary Outcome Measure Information:
Title
Satisfaction of pain control during admission
Description
Patient satisfaction about pain control
Time Frame
Up to 56 hours
Title
Patient outcome questionnaire (APS-POQ) analysis
Description
The analysis of APS-POQ outcome
Time Frame
Up to 56 hours
Title
SF-36 Questionnaire analysis
Description
The analysis of SF-36
Time Frame
Up to 24 hours in screening period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaw-Yuan Wang, PhD
Phone
886-7-3121101
Ext
5583
Email
jayuwa@cc.kmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Chih Su, MD
Phone
886-7-3121101
Ext
5575
Email
lake0126@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaw-Yuan Wang, PhD
Organizational Affiliation
Kaohsiung Medical University Chung-Ho Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Municipal Ta-Tung Hospital
City
Kaohsiung
ZIP/Postal Code
80145
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang-Ming Chen, PhD
Phone
886-7-2911101
Email
fchen@cc.kmu.edu.tw
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaw-Yuan Wang, PhD
Phone
886-7-3121101
Ext
5583
Email
jayuwa@cc.kmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Wei-Chih Su, MD
Phone
886-7-3121101
Ext
5575
Email
lake0126@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Hsiang-Lin Tsai, PhD
First Name & Middle Initial & Last Name & Degree
Wei-Chih Su, MD
Facility Name
Kaohsiung Municipal Siaogang Hospital
City
Kaohsiung
ZIP/Postal Code
812
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chieh-Han Chuang, MD
Phone
886-7-8036783
Ext
3442
Email
0790151@kmhk.org.tw

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23336265
Citation
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Results Reference
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Citation
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Citation
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Effect of Good Pain Management (GPM) Ward Program on Moderate to Severe Cancer Pain Patients

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