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Completed

NCT Number: NCT02664987

Analgesic Treatment for Cancer Pain in South East Asia

This study is planned to investigate the pain control status in cancer patients in 6 South East Asian countries through evaluation of prescription pattern of analgesics, satisfaction of pain control, quality of life and assessment of the adequacy of pain control and relationship among these factors in cancer patients with pain. Cancer pain is undermanaged and it is hoped that this study will be used as a reference for effective cancer pain management in these countries.

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Key information

Conditions

Pain Agnosia Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (over 18 years) cancer patients [country variation would be accepted based on the definition of adults]
  • Cancer has been diagnosed pathologically
  • Out-patients with cancer pain due to cancer itself or its treatment
  • Patients being treated with any analgesics for more than one month for the management of cancer pain at enrolment
  • Patients who are willing to voluntarily sign the study consent form

Exclusion criteria

  • Patients who have had an operation for any reasons within 3 months prior to the enrolment
  • Patients with any oncologic emergency
  • Patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry
  • Insufficient ability or willingness to cooperate
  • Patients who are judged not suitable to participate in this study by the investigator
  • Patients who are participating in any other interventional clinical trials for cancer treatment or supportive care

Treatment and study plan

Patients receiving cancer pain treatment

Other

Primary outcomes

  1. Prescription Pattern of Analgesics (Opioid or Non-opioid)

    Time frame: Day 1

    At Visit 1 (Day 1) which was the only visit in the study, data was collected on whether each patient was receiving only opioid, only non-opioid or both opioid and non-opioid analgesic treatments for pain control.

  2. Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators

    Time frame: Day 1

    The scale used to measure a patient's satisfaction with pain control ranges from 1 to 5:

    • Very satisfied
    • Satisfied
    • Acceptable
    • Dissatisfied
    • Very dissatisfied

    Patients and Investigators will each indicate their opinion on separate scales.

  3. Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient

    Time frame: Day 1

    EQ-5D-3L summary indices were calculated using the algorithm developed based on the valuation of EQ-5D-3L health states from an adult Thai population (Tongsiri & Cairns, 2011). Applying the Thai algorithm, EQ-5D-3L summary indices range from -0.45 to 0.80, with an EQ-5D-3L summary index of 0.80 indicating the best overall health-related quality of life.

  4. Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient

    Time frame: Past 1 day up to Day 1

    Patients indicated their pain intensity using a numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

    Their current pain intensity and pain in the last 24 hours were indicated on separate scales. A higher score indicates higher pain intensity.

Secondary outcomes

  1. Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient

    Time frame: Past 7 days up to Day 1

    Patients answered "yes" or "no" to the following question:

    "Have you had trouble sleeping due to your cancer pain within the last 7 days?"

  2. Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale

    Time frame: Day 1

    The Eastern Cooperative Oncology Group Performance Status (ECOG PS) scale ranges from 0 to 4:

    0- Fully active, able to carry on all pre-disease performance without restriction

    • Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
    • Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
    • Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
    • Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

    A higher score indicates greater functional impairment.

Sponsors and collaborators

Lead sponsor

Mundipharma Pte Ltd.

Industry

Registry information

Official study title

A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries

Acronym: ACE

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2016
Registry last updated
Oct 31, 2016

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.

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