Treatment of Breakthrough Cancer Pain According to European Guidelines

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breakthrough Cancer Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients of any ethnic origin of ≥ 18 years. Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or cytologic diagnosis), with BTcP, as assessed by the Investigator. Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses (OMEDD) of at least 60 mg. Drugs for BTcP treatment, if any, must be used according to the relevant SmPC. Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1, or 2. Patients with life expectancy > 3 months. Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent. Exclusion Criteria: Patients with previous or current history of a clinically significant neurological/psychiatric disorder and/or any substance abuse or dependence that, according to the Investigator's judgement, can impair the study end-points/results. Patients who have been taking antidepressants and/or drugs acting on pain and who take them on a regular basis during the observation period, can be enrolled. Any medical condition or situation complicating the collection of study data, as determined by the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GROUP A: Patients adherent to BTcP European Guidelines<br> | |
| GROUP B: Patients non Adherent to BTcP European Guidelines<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 4 weeks of observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APM algorithm | BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2) | 0, 1, 2, 3, 4 weeks of observation | 
| Tool-BAT | BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2) | 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) | 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). | 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 | 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 | 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 | 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 | at 2 and 4 weeks of observation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breakthrough cancer pain, Cancer, BTcP, Background pain