Clinical trial NCT02664987: Analgesic Treatment for Cancer Pain in South East Asia
Official title: A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: pain management, pain control, cancer
Lead sponsor: Mundipharma Pte Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 462
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were selected from government and private hospitals that see cancer patients.

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.


Eligibility 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

Primary outcomes:
measure: Prescription Pattern of Analgesics (Opioid or Non-opioid)
timeFrame: Day 1
measure: Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators
timeFrame: Day 1
measure: Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient
timeFrame: Day 1
measure: Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient
timeFrame: Past 1 day up to Day 1
Secondary outcomes:
measure: Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient
timeFrame: Past 7 days up to Day 1
measure: Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
References:
citation: Thinh DHQ, Sriraj W, Mansor M, Tan KH, Irawan C, Kurnianda J, Nguyen YP, Ong-Cornel A, Hadjiat Y, Moon H, Javier FO. Analgesic Prescription Patterns and Pain Outcomes in Southeast Asia: Findings From the Analgesic Treatment of Cancer Pain in Southeast Asia Study. J Glob Oncol. 2018 Sep;4:1-10. doi: 10.1200/JGO.17.00055.
citation: Thinh DHQ, Sriraj W, Mansor M, Tan KH, Irawan C, Kurnianda J, Nguyen YP, Ong-Cornel A, Hadjiat Y, Moon H, Javier FO. Patient and Physician Satisfaction with Analgesic Treatment: Findings from the Analgesic Treatment for Cancer Pain in Southeast Asia (ACE) Study. Pain Res Manag. 2018 Apr 18;2018:2193710. doi: 10.1155/2018/2193710. eCollection 2018.