Clinical trial NCT03155516: Effect of Good Pain Management (GPM) Ward Program on Moderate to Severe Cancer Pain Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Pain
Keywords: Cancer pain
GPM
pain assessment
Lead sponsor: Taiwan Mundipharma Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain management index (PMI) assessment
timeFrame: Up to 56 hours
Secondary outcomes:
measure: Satisfaction of pain control during admission
timeFrame: Up to 56 hours
measure: Patient outcome questionnaire (APS-POQ) analysis
timeFrame: Up to 56 hours
measure: SF-36 Questionnaire analysis
timeFrame: Up to 24 hours in screening period
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Siaogang Hospital
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Jaw-Yuan Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Su WC, Chuang CH, Chen FM, Tsai HL, Huang CW, Chang TK, Hou MF, Wang JY. Effects of Good Pain Management (GPM) ward program on patterns of care and pain control in patients with cancer pain in Taiwan. Support Care Cancer. 2021 Apr;29(4):1903-1911. doi: 10.1007/s00520-020-05656-x. Epub 2020 Aug 15.