The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

Cancer Clinical Trial

Official title:

The Effectiveness of Cancer Pain Management Including Early Pain Intervention, Early Multi Modality Treatment and Closed Follow up in Siriraj Outpatient Pain Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474406
• Other study ID #: Si 622/2017
• Status: Completed
• Start date: January 3, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: February 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer pain patients

• more than 18 years old

Exclusion Criteria:

• Clinical instability

• Cannot read and write

• Do not know the diagnosis

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Chronic Pain
• Pain, Chronic

Intervention

Other:
• follow up system and multimodality approach
To provide a new service system for cancer pain in pain clinic by early detecting red flag sign to consult other departments, early alleviating severe pain, following patients intensively by telephone call and giving pain education

Locations

Country	Name	City	State
Thailand	Faculty of medicine Siriraj Hospital Mahidol University	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of Pain.	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.	Approximately 12 wks from the baseline
Secondary	Total Brief Pain Inventory (BPI)	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	Approximately 12 wks from the baseline
Secondary	Edmonton Symptom Assessment System(ESAS)	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	Approximately 12 wks from the baseline
Secondary	Percentage of Moderate to Severe Sedation	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	Approximately 12 wks from the baseline.
Secondary	Percentage of Moderate to Severe Neausea and Vomitting	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)	Approximately 12 wks from the baseline
Secondary	Percentage of Moderate to Severe Constipation	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	Approximately 12 wks from the baseline
Secondary	Percentage of Satisfied With the Service (Score=3)	Satisfied score; 1=Dissatisfied; 2=Neutral; 3=Satisfied	Approximately 12 wks from the baseline.