The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

Completed

• Conditions: Cancer; Pain, Chronic

• Registration Number: NCT03474406
• Lead Sponsor: Mahidol University

Brief Summary

-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. In order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system

Detailed Description

* Objectives:Primary outcome is study the effectiveness of new approach and closed follow up system by relief pain intensity 30% at 3 month up to 80% of all new cancer pain patients in OPD setting Secondary outcomes are quality of life (BPI,ESAS), side effect of treatments and the contributing factors that impact on the outcomes

* Study design:A prospective observational study

* Sample size : 150

* Data collection: General information: age, gender, body weight, height, religion, residence, care giver, occupation, income, education, medical problem Clinical pain information: primary diagnosis, staging, cancer site, current medications Clinical assessment: at three study time points: baseline (initial assessment) and the three subsequent follow-ups (FU1, FU2 and FU3)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-02-18
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Primary Completion: 2019-03-30
• Study Completion: 2019-06-30
• Results First Submitted: 2020-12-09
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Results First Posted: 2021-03-16
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Cancer pain patients
• more than 18 years old

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Exclusion Criteria

• Clinical instability
• Cannot read and write
• Do not know the diagnosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of Pain.	Approximately 12 wks from the baseline	Numerical Pain Rating Scale Total score 0-10 (0 is best outcome, 10 is worst outcome) 0-3 is mild pain, 4-7 is moderate pain, 7-10 is severe pain.

Secondary Outcome Measures

Name	Time	Method
Total Brief Pain Inventory (BPI)	Approximately 12 wks from the baseline	To assess the severity of pain and impact on functioning that included worst pain in last 24 hrs, least pain in last 24 hrs, pain average, pain right now, general activity, mood, walking ability, normal work, relationship with other, sleep and enjoyment of life.; Each symptoms scales 0-10 (0 mean no symptom, not interfere, 10 mean most symptom, most interfere) total 70 scores
Edmonton Symptom Assessment System(ESAS)	Approximately 12 wks from the baseline	To assess multi-directional of patients quality of life, included 9 symptoms ( pain,tired, neausea, depress, anxious, drowsiness, appetite, feeling of well being, shortness of breath) Each symptoms scales 0-9 (0 mean no Symptom, 9 mean most severe symptom) total ESAS 90 scores
Percentage of Moderate to Severe Sedation	Approximately 12 wks from the baseline.	Pasero Opioid-induced Sedation Scale (POSS); * S=sleep, easy to arouse; * 1=awake/alert; * 2= slight drowsy/easy aroused; * 3=Frequently drowsy, arousable, drifts off to sleep during conversation; * 4=Somnolent, minimal or no response to verbal and physical stimulation Score of 2-4 indicated moderate to severe sedation
Percentage of Moderate to Severe Neausea and Vomitting	Approximately 12 wks from the baseline	Four points scale to evaluate opioid induce nausea and vomiting Total scales 0-3 (0 is best outcome, 3 is worst outcome); * 0= no nausea and vomiting; * 1= mild symptom but not need any treatments. (only neausea); * 2= moderate symptom, need treatment, can control symptom. (have vomiting can control with medication); * 3= severe symptom, need treatment, cannot control symptom. (vomiting can not control with medication)
Percentage of Moderate to Severe Constipation	Approximately 12 wks from the baseline	Stool free interval 72 (sfi72) to evaluate opioid induce costipation (OIC): 0-4.; Total scale 0-4 (0 is best outcome, 4 is worst outcome); * 0 represented one defecation within the previous 72 hr; * 1 denoted mild constipation (no defecation within the last 72 h); * 2 referred to the use of a maximum of 3 laxatives; * 3 referred to the use of more than 3 laxatives; * 4 referred to the use of all laxatives have failed Score of 2-4 indicated moderate to severe constipation
Percentage of Satisfied With the Service (Score=3)	Approximately 12 wks from the baseline.	Satisfied score; * 1=Dissatisfied; * 2=Neutral; * 3=Satisfied

Trial Locations

Locations (1)

Faculty of medicine Siriraj Hospital Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand