Characterisation and Epidemiology of Breakthrough Cancer Pain in Spain
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About
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.
Full description
This study has been designed as a non-interventional, non post-authorization, cross-sectional, epidemiological study to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an non-selected, representative cohort of cancer outpatients with or without pain.
The study enrolled 3765 patients. This multicenter trial will be conducted in Spain. Data from participants will be collected through questionnaire and medical history in a single visit (up to 1 month).
Enrollment
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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
Trial design
3,765 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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