PainACENCT02664987

Analgesic Treatment for Cancer Pain in South East Asia

An observational study of Pain, run by Mundipharma Pte Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain
What is being tested?: Patients receiving cancer pain treatment
How many people: 462 participants
Where: No sites listed yet
Study dates: Sep 2015to Dec 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

About this study

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

Conditions: Pain
Being tested: Patients receiving cancer pain treatment
Keywords: pain management, pain control, cancer
Medical subject headings: Pain, Agnosia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patients receiving cancer pain treatmentOther

Study groups in NCT02664987
Study group	Role	What they receive
Patients receiving cancer pain treatment		Not described Receives: Other: Patients receiving cancer pain treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Past 1 day up to Day 1

Secondary outcomes (2)

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?"
Measured: 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
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.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Dec 2015

First posted27 Jan 2016 (estimated)
Study startSep 2015
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 462 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02664987
Sponsor's protocol ID: OPD14-AP-401
Acronym: ACE
Status last verified: Sep 2016
First submitted: 22 Jan 2016
Last updated: 31 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 30241271
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.
PubMed 29849841

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Cross-sectional Study to Investigate the Pain Control Status in Cancer Patients in South East Asian Countries
ClinicalTrials.gov ID: NCT02664987
Acronym / sponsor ID: ACE / OPD14-AP-401
Conditions: Pain
Keywords: pain management, pain control, cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 462 participants (actual)
Lead sponsor: Mundipharma Pte Ltd.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 27 Jan 2016 (estimated)
Results: Posted 31 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
Patients receiving cancer pain treatment	–	Other: Patients receiving cancer pain treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects were selected from government and private hospitals that see cancer patients.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patients receiving cancer pain treatment	Other	Patients receiving cancer pain treatment

Primary outcome

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.
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.
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.
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.

2 secondary outcomes

Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient
Time frame: Past 7 days up to Day 1
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale
Time frame: Day 1

Results and safety

Results posted to the registry on 31 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Receiving Cancer Pain Treatment	462	462

Primary outcome: Prescription Pattern of Analgesics (Opioid or Non-opioid)

Time frame: Day 1. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Patients Receiving Cancer Pain Treatment n = 462
Opioid analgesics only	37.27 (31.83 to 42.92)
Non-opioid analgesics only	11.33 (7.58 to 15.31)
Opioid and non-opioid analgesics	51.40 (46.13 to 56.83)

Primary outcome: Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators

Time frame: Day 1. Number. Unit: percentage of patients

Measure	Patients Receiving Cancer Pain Treatment n = 462
Very satisfied- answered by patient	18.6
Satisfied- answered by patient	41.6
Acceptable- answered by patient	30.3
Dissatisfied- answered by patient	8.0
Very dissatisfied- answered by patient	1.5
Very satisfied- answered by Investigator	12.1
Satisfied- answered by Investigator	42.0
Acceptable- answered by Investigator	25.3

Primary outcome: Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient

Time frame: Day 1. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients Receiving Cancer Pain Treatment n = 462
Value	0.45 (0.30)

Primary outcome: 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. Mean (Standard Deviation). Unit: units on a scale

Measure	Patients Receiving Cancer Pain Treatment n = 462
Current pain intensity level	4.10 (2.61)
Pain intensity level in the last 24 hours	4.76 (2.47)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Receiving Cancer Pain Treatment	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30241271Thinh 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.
Derived from this study: PubMed 29849841Thinh 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Mundipharma Pte Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prescription Pattern of Analgesics (Opioid or Non-opioid) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02664987, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.