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Cancer Pain

Pain

Neurologic Manifestations

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.

Treatment of Breakthrough Cancer Pain According to European Guidelines

Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.

Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)

BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)

BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)

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)

Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).

Number of specialist/GP visits due to cancer pain during the observation period

Number of hospitalizations due to cancer pain during the observation period

Length of hospitalizations (days) due to cancer pain during the observation period

Number of admittances to ER due to cancer pain during the observation period

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Breakthrough Cancer Pain According to European Guidelines	NCT04468490	Breakthrough Ca...		18 Years -	Aziende Chimiche Riunite Angelini Francesco S.p.A
Treatment of Breakthrough Cancer Pain According to European Guidelines	NCT04468490	Breakthrough Ca...		18 Years -	Aziende Chimiche Riunite Angelini Francesco S.p.A

Spots Global Cancer Trial Database for background pain