Effect of Good Pain Management (GPM) Ward Program on Moderate to Severe Cancer Pain Patients
- Conditions
- PainCancer
- Interventions
- Other: Current practice procedureOther: Good pain management (GPM) procedure
- Registration Number
- NCT03155516
- Lead Sponsor
- Taiwan Mundipharma Pharmaceuticals Ltd.
- 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.
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Ward Current practice procedure Current practice controlled ward GPM Ward Good pain management (GPM) procedure Good Pain management ward
- Primary Outcome Measures
Name Time Method Pain management index (PMI) assessment Up to 56 hours The change of mean PMI score, pain-reporting rate and adequacy of pain treatment using pain management index
- Secondary Outcome Measures
Name Time Method Satisfaction of pain control during admission Up to 56 hours Patient satisfaction about pain control
Patient outcome questionnaire (APS-POQ) analysis Up to 56 hours The analysis of APS-POQ outcome
SF-36 Questionnaire analysis Up to 24 hours in screening period The analysis of SF-36
Trial Locations
- Locations (3)
Kaohsiung Municipal Ta-Tung Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Municipal Siaogang Hospital
🇨🇳Kaohsiung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan