Pain
Conditions
Keywords
pain management, pain control, cancer
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.
Interventions
OTHERPatients receiving cancer pain treatment
Sponsors
Mundipharma Pte Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prescription Pattern of Analgesics (Opioid or Non-opioid) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient | Past 7 days up to Day 1 | Patients answered yes or no to the following question: Have you had trouble sleeping due to your cancer pain within the last 7 days? |
| Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale | Day 1 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Receiving Cancer Pain Treatment Single arm -- Patients receiving cancer pain treatment | 462 |
| Total | 462 |
Baseline characteristics
| Characteristic | Patients Receiving Cancer Pain Treatment |
|---|---|
| Age, Continuous | 55.14 years STANDARD_DEVIATION 13.39 |
| Sex: Female, Male Female | 248 Participants |
| Sex: Female, Male Male | 214 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Past 1 day up to Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Receiving Cancer Pain Treatment | Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient | Current pain intensity level | 4.10 units on a scale | Standard Deviation 2.61 |
| Patients Receiving Cancer Pain Treatment | Intensity of Pain Currently and Over Past 24 Hours as Measured by NRS Scores Indicated by Patient | Pain intensity level in the last 24 hours | 4.76 units on a scale | Standard Deviation 2.47 |
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.
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Receiving Cancer Pain Treatment | Prescription Pattern of Analgesics (Opioid or Non-opioid) | Opioid analgesics only | 37.27 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Prescription Pattern of Analgesics (Opioid or Non-opioid) | Non-opioid analgesics only | 11.33 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Prescription Pattern of Analgesics (Opioid or Non-opioid) | Opioid and non-opioid analgesics | 51.40 percentage of patients |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Receiving Cancer Pain Treatment | Quality of Life as Measured Using EQ-5D-3L Questionnaire Answered by Patient | 0.45 units on a scale | Standard Deviation 0.3 |
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: 1. Very satisfied 2. Satisfied 3. Acceptable 4. Dissatisfied 5. Very dissatisfied Patients and Investigators will each indicate their opinion on separate scales.
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Very satisfied- answered by patient | 18.6 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Satisfied- answered by patient | 41.6 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Acceptable- answered by patient | 30.3 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Dissatisfied- answered by patient | 8.0 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Very dissatisfied- answered by patient | 1.5 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Very satisfied- answered by Investigator | 12.1 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Satisfied- answered by Investigator | 42.0 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Acceptable- answered by Investigator | 25.3 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Dissatisfied- answered by Investigator | 19.1 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Satisfaction With Patient's Pain Control as Measured by 5-point Scale Answered by Patients and Investigators | Very dissatisfied- answered by Investigator | 1.5 percentage of patients |
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 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.
Time frame: Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Receiving Cancer Pain Treatment | Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale | 0- Fully active | 14.9 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale | 1- Restricted strenuous activity | 42.7 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale | 2- Ambulatory | 26.6 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale | 3- Limited self-care | 13.6 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale | 4- Completely disabled | 2.2 percentage of patients |
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?
Time frame: Past 7 days up to Day 1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Receiving Cancer Pain Treatment | Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient | No trouble sleeping | 45.2 percentage of patients |
| Patients Receiving Cancer Pain Treatment | Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient | Had trouble sleeping | 54.8 percentage of patients |