An observational study in Breakthrough Cancer Pain, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Terminated at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-27.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Observational
Pain is a frequent symptom in cancer patients with a negative impact on the quality of life (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain, manifesting spontaneously or related to a specific predictable or unpredictable triggering factor, despite stable and adequately controlled basal pain". The present study assesses the percentage of patients who are treated according to the European guidelines (ESMO, 2018) for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.
Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with breakthrough pain should have this pain specifically assessed, starting from the appropriate diagnosis. Recently developed European guidelines support this approach and recommend treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick start and short duration of the pain episode.Nevertheless, despite the drug treatment for BTcP has undergone knowledge advances in recent years and several guidelines have been published, this condition is still often inadequately managed.
The present study will assess the percentage of patients who are treated according to the European guidelines for BTcP management in 4 European countries and the impact of the adherence to guidelines on patients' pain relief and QoL.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 131 is close to the median of 140 across 68 observational studies indexed under Cancer Pain.
Browse Cancer Pain studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population includes patients with BTcP.
Exclusion Criteria:
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)
Time frame: 4 weeks of observation
APM algorithm
BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)
Time frame: 0, 1, 2, 3, 4 weeks of observation
Tool-BAT
BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)
Time frame: at 0, 1, 2, 3, 4 weeks of observation
EORTC QLQ-C30
Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)
Time frame: at 0, 1, 2, 3, 4 weeks of observation
Patient Global Impression of Change (PGIC)
Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).
Time frame: at 0, 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)
Number of specialist/GP visits due to cancer pain during the observation period
Time frame: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of hospitalizations)
Number of hospitalizations due to cancer pain during the observation period
Time frame: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Length of hospitalizations)
Length of hospitalizations (days) due to cancer pain during the observation period
Time frame: at 2 and 4 weeks of observation
Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)
Number of admittances to ER due to cancer pain during the observation period
Time frame: at 2 and 4 weeks of observation
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Aziende Chimiche Riunite Angelini Francesco S.p.A