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

May 15, 2017 updated by: Taiwan Mundipharma Pharmaceuticals Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hsiang-Lin Tsai, PhD
        • Sub-Investigator:
          • Wei-Chih Su, MD
      • Kaohsiung, Taiwan, 812
        • Recruiting
        • Kaohsiung Municipal Siaogang Hospital
        • Contact:
      • Kaohsiung, Taiwan, 80145
        • Recruiting
        • Kaohsiung Municipal Ta-Tung Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GPM Ward
Good Pain management ward
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.
ACTIVE_COMPARATOR: Control Ward
Current practice controlled ward
Other: Current practice procedure
Current practice clinical procedure for pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 56 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiwan Mundipharma Pharmaceuticals Ltd.

Investigators

  • Principal Investigator: Jaw-Yuan Wang, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 30, 2016

Primary Completion (ANTICIPATED)

August 29, 2019

Study Completion (ANTICIPATED)

August 29, 2019

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (ACTUAL)

May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPM16-TW-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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