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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving cancer pain treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients receiving cancer pain treatment | Other |
|
| 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:
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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects were selected from government and private hospitals that see cancer patients.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. 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. | |
| 29849841 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving Cancer Pain Treatment | Single arm -- Patients receiving cancer pain treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving Cancer Pain Treatment | Single arm -- Patients receiving cancer pain treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of patients | Day 1 |
|
|
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This is an observational study with no investigational product involved. Therefore, there were no serious and non-serious adverse events collected and assessed as part of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving Cancer Pain Treatment | Single arm -- Patients receiving cancer pain treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Leck | Mundipharma Pte Ltd | +65 6511 1165 | info.rma@mundipharma.com.sg |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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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
A higher score indicates greater functional impairment. |
| Day 1 |
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | 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:
Patients and Investigators will each indicate their opinion on separate scales. | Posted | Number | percentage of patients | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Day 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | Past 1 day up to Day 1 |
|
|
|
| Secondary | 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?" | Posted | Number | percentage of patients | Past 7 days up to Day 1 |
|
|
|
| Secondary | 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
A higher score indicates greater functional impairment. | Posted | Number | percentage of patients | Day 1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
The Investigator may not publish the results of the study without prior approval from Mundipharma.
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Dissatisfied- answered by patient |
|
| Very dissatisfied- answered by patient |
|
| Very satisfied- answered by Investigator |
|
| Satisfied- answered by Investigator |
|
| Acceptable- answered by Investigator |
|
| Dissatisfied- answered by Investigator |
|
| Very dissatisfied- answered by Investigator |
|
| Title | Measurements |
|---|---|
|
| 3- Limited self-care |
|
| 4- Completely disabled |
|