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Analgesic Treatment for Cancer Pain in South East Asia (ACE)

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ClinicalTrials.gov Identifier: NCT02664987
Recruitment Status : Completed
First Posted : January 27, 2016
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Mundipharma Pte Ltd.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Pain Other: Patients receiving cancer pain treatment

Study Design
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Study Type : Observational
Actual Enrollment : 462 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients receiving cancer pain treatment Other: Patients receiving cancer pain treatment


Outcome Measures
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Primary Outcome Measures :
  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:

    1. Very satisfied
    2. Satisfied
    3. Acceptable
    4. Dissatisfied
    5. 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 Outcome Measures :
  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

    1. 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
    2. Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
    3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
    4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair

    A higher score indicates greater functional impairment.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects were selected from government and private hospitals that see cancer patients.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who have had an operation for any reasons within 3 months prior to the enrolment
  2. Patients with any oncologic emergency
  3. Patients who had any interventional therapy (e.g. nerve block, neurolytic procedures) related to their cancer pain within 6 weeks of study entry
  4. Insufficient ability or willingness to cooperate
  5. Patients who are judged not suitable to participate in this study by the investigator
  6. Patients who are participating in any other interventional clinical trials for cancer treatment or supportive care
Contacts and Locations
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More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mundipharma Pte Ltd.
ClinicalTrials.gov Identifier: NCT02664987    
Other Study ID Numbers: OPD14-AP-401
First Posted: January 27, 2016    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016
Last Verified: September 2016
Keywords provided by Mundipharma Pte Ltd.:
pain management, pain control, cancer