Skip to main content
OpenTrials
Completed

NCT Number: NCT03474406

The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

-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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Chronic Cancer Chronic Pain Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cancer pain patients
  • more than 18 years old

Exclusion criteria

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

Treatment and study plan

follow up system and multimodality approach

Other

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

Primary outcomes

  1. Improvement of Pain.

    Time frame: 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 outcomes

  1. Total Brief Pain Inventory (BPI)

    Time frame: 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

  2. Edmonton Symptom Assessment System(ESAS)

    Time frame: 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

  3. Percentage of Moderate to Severe Sedation

    Time frame: 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

  4. Percentage of Moderate to Severe Neausea and Vomitting

    Time frame: 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)

  5. Percentage of Moderate to Severe Constipation

    Time frame: 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

  6. Percentage of Satisfied With the Service (Score=3)

    Time frame: Approximately 12 wks from the baseline.

    Satisfied score

    • 1=Dissatisfied
    • 2=Neutral
    • 3=Satisfied

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.