NCT03155516

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Taiwan Mundipharma Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cancer
• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-30
• Primary completion: 2019-08-29
• Completion: 2019-08-29
• First posted: 2017-05-16
• Last updated: 2017-05-16

Locations

3 sites across 1 country: Taiwan