Trial Outcomes & Findings for Analgesic Treatment for Cancer Pain in South East Asia (NCT NCT02664987)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

462 participants

Primary outcome timeframe

Day 1

Results posted on

2016-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Receiving Cancer Pain Treatment Single arm -- Patients receiving cancer pain treatment
Overall Study STARTED	462
Overall Study COMPLETED	462
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Analgesic Treatment for Cancer Pain in South East Asia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- Patients receiving cancer pain treatment
Age, Continuous	55.14 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	248 Participants n=5 Participants
Sex: Female, Male Male	214 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- Patients receiving cancer pain treatment
Prescription Pattern of Analgesics (Opioid or Non-opioid) Opioid analgesics only	37.27 percentage of patients Interval 31.83 to 42.92
Prescription Pattern of Analgesics (Opioid or Non-opioid) Non-opioid analgesics only	11.33 percentage of patients Interval 7.58 to 15.31
Prescription Pattern of Analgesics (Opioid or Non-opioid) Opioid and non-opioid analgesics	51.40 percentage of patients Interval 46.13 to 56.83

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- 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
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
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
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
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
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
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
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
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
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

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- 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 0.30

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- 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
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

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Outcome measures
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- 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
Sleep Disturbance Within Last 7 Days Assessed Using Questionnaire Answered by Patient Had trouble sleeping	54.8 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients Receiving Cancer Pain Treatment n=462 Participants Single arm -- 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
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale 1- Restricted strenuous activity	42.7 percentage of patients
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale 2- Ambulatory	26.6 percentage of patients
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale 3- Limited self-care	13.6 percentage of patients
Patient's Performance Status as Measured by Investigator's Rating on ECOG PS Scale 4- Completely disabled	2.2 percentage of patients

Adverse Events

Patients Receiving Cancer Pain Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Valerie Leck

Mundipharma Pte Ltd

Phone: +65 6511 1165

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Investigator may not publish the results of the study without prior approval from Mundipharma.
Publication restrictions are in place

Restriction type: OTHER