Clinical trial NCT03474406: The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Chronic
Cancer
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The new patients with cancer pain in Siriraj outpatients pain clinic

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)

Eligibility criteria: Inclusion Criteria:

* Cancer pain patients
* more than 18 years old

Exclusion Criteria:

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

Primary outcomes:
measure: Improvement of Pain.
timeFrame: Approximately 12 wks from the baseline
Secondary outcomes:
measure: Total Brief Pain Inventory (BPI)
timeFrame: Approximately 12 wks from the baseline
measure: Edmonton Symptom Assessment System(ESAS)
timeFrame: Approximately 12 wks from the baseline
measure: Percentage of Moderate to Severe Sedation
timeFrame: Approximately 12 wks from the baseline.
measure: Percentage of Moderate to Severe Neausea and Vomitting
timeFrame: Approximately 12 wks from the baseline
measure: Percentage of Moderate to Severe Constipation
timeFrame: Approximately 12 wks from the baseline
measure: Percentage of Satisfied With the Service (Score=3)
timeFrame: Approximately 12 wks from the baseline.
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of medicine Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Pain Clinic Siriraj Hospital
role: PRINCIPAL_INVESTIGATOR
References: