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

Mundipharma

Status: Unknown

Conditions: Cancer; Pain

Treatments: Other: Current practice procedure; Other: Good pain management (GPM) procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT03155516

GPM16-TW-401

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 2 patient groups

GPM Ward

Experimental group

Description:

Good Pain management ward

Treatment:

Other: Good pain management (GPM) procedure

Control Ward

Active Comparator group

Description:

Current practice controlled ward

Treatment:

Other: Current practice procedure