Analgesic Treatment for Cancer Pain in South East Asia

Cancer Pain Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02664987
• Other study ID #: OPD14-AP-401
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: January 22, 2016
• Start date: September 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Mundipharma Pte Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of HealthSingapore: Health Sciences AuthorityPhilippines : Food and Drug AdministrationIndonesia: National Agency of Drug and Food ControlThailand: Food and Drug AdministrationVietnam: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 paindue 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 trialsfor cancer treatment or supportive care

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• Patients receiving cancer pain treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Pte Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prescription pattern of analgesics (opioid or non-opioid)		Day 1	No
Primary	Satisfaction of pain control as measured by 5-point scale answered by both patient and Investigator		Day 1	No
Primary	Quality of life as measured using EQ-5D-3L questionnaire answered by patient		Day 1	No
Primary	Intensity of pain currently and over past 24 hours as measured by NRS scores indicated by patient		24 hours	No
Secondary	Sleep satisfaction within last 7 days assessed using questionnaire answered by patient		7 days	No
Secondary	Adequacy of patient's pain control answered by Investigator		Day 1	No