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

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Patients receiving cancer pain treatment

• Study Type: Observational
• Enrollment (Actual): 462

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects were selected from government and private hospitals that see cancer patients.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients receiving cancer pain treatment	Other: Patients receiving cancer pain treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription Pattern of Analgesics (Opioid or Non-opioid)	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.	Day 1
Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators	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.	Day 1
Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient	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.	Day 1
Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient	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.	Past 1 day up to Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient	Patients answered "yes" or "no" to the following question: "Have you had trouble sleeping due to your cancer pain within the last 7 days?"	Past 7 days up to Day 1
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale	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.	Day 1

Collaborators and Investigators

• Sponsor: Mundipharma Pte Ltd.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: January 22, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: pain management, pain control, cancer
• Other Study ID Numbers: OPD14-AP-401