N/A
N=3,765
Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
Breakthrough Cancer Pain
Bottom Line
View on ClinicalTrials.gov: NCT02899884 ↗Enrolled (actual)
3,765
Serious AEs
—
Results posted
Nov 2019
Primary outcome: Primary: Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation — 14.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No Intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Cancer Participants With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation |
14.3 | — |
| PRIMARY Percentage of Cancer Participants With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation |
48.3 | — |
| SECONDARY Number of New Participants Diagnosed With Breakthrough Cancer Pain From the Total Number of Cancer Participants Seen in Consultation |
105 | — |
| SECONDARY Percentage of New Participants Diagnosed With Breakthrough Cancer Pain From the Number of Cancer Participants With Pain Seen in Consultation |
19.3 | — |
| SECONDARY Pain Characterization With the Alberta Breakthrough Pain Assessment |
53.2; 36.3; 10.5; 57.7; 33.0; 9.3 | — |
| SECONDARY Pain Severity and Pain Interference as Assessed by Brief Pain Inventory (BPI) Questionnaire Score |
5.33; 6.07 | — |
| SECONDARY Pain Assessment Using the Numeric Rating Scale |
— | — |
| SECONDARY Quality of Life Assessment Using the Short Form-12 (SF-12) Questionnaire Score |
28.53; 36.87 | — |
| SECONDARY Participant's Performance as Assessed by the Karnofsky Scale Score |
0.2; 0.5; 0.8; 1.4; 2.2; 2.9 | — |
Summary
The purpose of this study is to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an unselected, representative cohort of cancer outpatients with or without pain who attend consultations.
Eligibility Criteria
Inclusion Criteria
- Participants≥ 18 years old
- Participants with baseline cancer pain that is adequately controlled with opioids
- Presence of episodes of breakthrough pain associated with the cancer pain
- Meeting the diagnostic criteria for breakthrough cancer pain (participant history and Portenoy's criteria) and the Davies algorithm
- Participants who are not receiving treatment for breakthrough cancer pain. It is not permitted the inclusion of participants receiving treatment for breakthrough cancer pain in order to avoid bias that may affect the characterization or taxonomy of breakthrough cancer pain
- Signing of the informed consent
Exclusion Criteria
- Severe mental illness
- Any medical condition or situation complicating the collection of study data as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT02899884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.