Trial Outcomes & Findings for Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain (NCT NCT02899884)
NCT ID: NCT02899884
Last Updated: 2019-11-22
Results Overview
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
COMPLETED
3765 participants
Month 1
2019-11-22
Participant Flow
Participants took part in the study at 32 investigative sites in Spain from 14 November 2016 to 16 July 2018.
Participants with a diagnosis of cancer pain were enrolled and observed to characterize the participants with breakthrough pain.
Participant milestones
| Measure |
Cohort 1
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Overall Study
STARTED
|
3765
|
|
Overall Study
COMPLETED
|
3765
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Number analyzed is the number of participants with data available for this baseline measure.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3765 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 13 • n=3721 Participants • Number analyzed is the number of participants with data available for this baseline measure.
|
|
Sex: Female, Male
Female
|
1789 Participants
n=3736 Participants • Number analyzed is the number of participants with data available for this baseline measure.
|
|
Sex: Female, Male
Male
|
1947 Participants
n=3736 Participants • Number analyzed is the number of participants with data available for this baseline measure.
|
|
Region of Enrollment
Spain
|
3765 Participants
n=3765 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database.
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Outcome measures
| Measure |
Cohort 1
n=3765 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
|
14.3 percentage of participants
Interval 13.2 to 15.4
|
PRIMARY outcome
Timeframe: Month 1Population: Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database.
Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Outcome measures
| Measure |
Cohort 1
n=1117 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
|
48.3 percentage of participants
Interval 45.3 to 51.2
|
SECONDARY outcome
Timeframe: Month 1Population: Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database. Number analyzed is the total number of participants with data available for the time of diagnosis of breakthrough cancer pain.
Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Outcome measures
| Measure |
Cohort 1
n=3765 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation
|
105 Participants
|
SECONDARY outcome
Timeframe: Month 1Population: Participants with cancer pain from the Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database, with data available for the time of diagnosis of breakthrough cancer pain.
Participants diagnosed during the study and were not diagnosed previously were reported as new participants with breakthrough cancer pain. Breakthrough cancer pain was defined as the temporary exacerbation of pain occurring either spontaneously or in relation to a specific, predictable or unpredictable trigger in spite of relatively stable and adequately controlled baseline pain.
Outcome measures
| Measure |
Cohort 1
n=544 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation
|
19.3 percentage of participants
Interval 16.0 to 22.6
|
SECONDARY outcome
Timeframe: Month 1Population: Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given question.
The Alberta Breakthrough Pain Assessment Tool (ABPAT) consisted of a participant's self-reporting section (15 questions) out of which 4 questions of the tool were not included as they were related to the treatment for breakthrough cancer pain. The questions included: Q1-Relationship to baseline pain, Q2a-Last time experienced, Q3b-Frequency, Q4b-Intensity of pain at peak, Q5-Location (most frequent - ≥5%), Q6-Quality (those present in ≥20%), Q7-Time from onset to peak intensity, Q8-Time from onset \[take medication\] to end of episode, Q9-Cause(s) (triggers) (Those present in ≥20%), Q10-Predictability, Q11-General relief (those present in ≈20% or more participants) and questions completed by nurse/physician (N/P), Q1-Etiology of breakthrough pain, Q2-Inferred pathophysiology of breakthrough pain. Percentage of participants were categorized into the answers for each of these questions.
Outcome measures
| Measure |
Cohort 1
n=195 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1, Brief Flare-up of Baseline Pain
|
53.2 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1, Different from Baseline Pain
|
36.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1, Not Sure
|
10.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2a, Today
|
57.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2a, Yesterday
|
33.0 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2a, Before then
|
9.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q3b, Usual
|
62.6 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q3b, Better
|
8.4 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q3b, Worse
|
29.1 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q4b, Mild
|
1.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q4b, Moderate
|
16.0 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q4b, Severe
|
82.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q5, Lumbar
|
20.0 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q5, Hips
|
6.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q5, Abdominal
|
6.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q5, Back
|
6.2 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q5, Thoracolumbar
|
5.1 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q5, Thoracic
|
5.1 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Stabbing
|
57.9 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Splitting
|
29.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Sharp
|
29.2 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Punishing-Cruel
|
27.2 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Heavy
|
26.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Hot-Burning
|
25.6 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q6, Fearful
|
21.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q7, More than 0 and Up to 10 Minutes
|
57.4 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q7, More than 10 and Up to 30 Minutes
|
24.1 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q7, More than 30 Minutes
|
8.2 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q7, It is Hard to Say Exactly When It Started
|
10.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q8, More than 0 and Up to 10 minutes
|
18.8 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q8, More than 10 and Up to 30 minutes
|
37.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q8, More than 30 Minutes
|
33.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q8, I am Not on Any Breakthrough Pain Medication
|
10.4 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q9, Movement in Bed
|
33.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q9, Walking
|
31.8 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q9, Standing
|
29.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q11, Lying
|
37.4 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q9, Sitting
|
19.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q9, Coughing
|
19.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q10, I Can Never Predict When It will Occur
|
19.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q10, I Can Rarely Predict When It will Occur
|
17.4 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q10, I Can Sometimes Predict When It will Occur
|
20.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q10, I Can Often Predict When It will Occur
|
30.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q10, I Can Always Predict When It will Occur
|
12.3 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q11, Use of Scheduled Pain Medication
|
19.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q11, Unsure
|
19.5 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1:N/P,Pain Related to the Site of Active Cancer
|
78.0 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1:N/P, Related to Body/Cancer's Systemic Effects
|
5.9 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1:N/P,Pain Related to Anticancer Treatment
|
9.7 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1:N/P,Pain Caused by a Concurrent Disorder
|
4.8 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q1:N/P,Unknown or Uncertain at this Time
|
1.6 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2:N/P,Somatic Nociceptive
|
55.9 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2:N/P,Visceral Nociceptive
|
16.1 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2:N/P,Neuropathic
|
19.9 percenatge of participants
|
|
Pain Characterization With the Alberta Breakthrough Pain Assessment
Q2:N/P,Unknown or Uncertain at this Time
|
8.1 percenatge of participants
|
SECONDARY outcome
Timeframe: Month 1Population: Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale. Number analyzed is the participants with data available for the given category.
The BPI questionnaire was used to assess the pain intensity (4 items) and interference with activities of daily living (7 items). Each item was given a score on a numerical scale from 0 (no pain/interference with activities of daily living) to 10 (worst pain imaginable/maximum impact on activities of daily living). The total score for pain intensity is the average of the four pain items. The total score of pain interference is the average score of the seven interference items. The higher score represents high impact.
Outcome measures
| Measure |
Cohort 1
n=196 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score
Pain Severity
|
5.33 score on a scale
Standard Deviation 1.78
|
|
Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score
Pain Interference
|
6.07 score on a scale
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Month 1Population: Data was not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 1Population: Participants from Prevalence Study Population, participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with breakthrough cancer pain who did not take any treatment for it and who administered the scale with data available for this outcome measure.
The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 (poor mental and physical quality of life) and 100 (better mental and physical quality of life).
Outcome measures
| Measure |
Cohort 1
n=188 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score
Physical Component SF-12
|
28.53 score on a scale
Standard Deviation 7.97
|
|
Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score
Mental Component SF-12
|
36.87 score on a scale
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: Month 1Population: Prevalence Study Population included participants with the prevalence of breakthrough cancer pain for whom data was collected in prevalence form in the database with data available for this outcome measure.
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which ranges between 0 (death) to 100 (participant asymptomatic with no evidence of illness). Higher score means higher ability to perform daily tasks. Participants with missing values in the Karnofsky scale were assigned to the worst score of 0, however, in these cases it is not 'death'.
Outcome measures
| Measure |
Cohort 1
n=3751 Participants
Participants with cancer pain that is adequately controlled with opioids were observed for a period of 1 month in this observational study.
|
|---|---|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 100
|
25.2 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 0
|
0.2 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 10
|
0.5 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 20
|
0.8 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 30
|
1.4 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 40
|
2.2 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 50
|
2.9 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 60
|
6.7 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 70
|
11.9 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 80
|
22.6 percentage of participants
|
|
Participant's Performance as Assessed by the Karnofsky Scale Score
Score 90
|
25.7 percentage of participants
|
Adverse Events
Cohort 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER