Analgesic Treatment for Cancer Pain in South East Asia

NCT02664987 | Completed Results

• 1 other identifier: OPD14-AP-401
• Study Type: observational
• Target: 462
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

pain management, pain control, cancer

Outcome Measures

Primary Outcomes (4)

• 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: 1. Very satisfied 2. Satisfied 3. Acceptable 4. Dissatisfied 5. 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 Outcomes (2)

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

  Past 7 days up to Day 1

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

  Day 1

Study Arms (1)

Patients receiving cancer pain treatment

Other: Patients receiving cancer pain treatment

Interventions

Patients receiving cancer pain treatment OTHER

Patients receiving cancer pain treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mundipharma Pte Ltd.: lead

Related Publications (2)

• 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.

  PMID: 30241271 DERIVED

• 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.

  PMID: 29849841 DERIVED

MeSH Terms

Conditions

Pain; Agnosia; Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Valerie Leck
• Organization: Mundipharma Pte Ltd

info.rma@mundipharma.com.sg

+65 6511 1165

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 31, 2016
• Results First Posted: October 31, 2016

Record last verified: 2016-09