Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
时间窗: 4 weeks of observation
Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)
次要结局
- APM algorithm(0, 1, 2, 3, 4 weeks of observation)
- EORTC QLQ-C30(at 0, 1, 2, 3, 4 weeks of observation)
- Patient Global Impression of Change (PGIC)(at 0, 2 and 4 weeks of observation)
- Tool-BAT(at 0, 1, 2, 3, 4 weeks of observation)
- Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)(at 2 and 4 weeks of observation)
- Healthcare resources consumed due to cancer pain (Number of hospitalizations)(at 2 and 4 weeks of observation)
- Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)(at 2 and 4 weeks of observation)
- Healthcare resources consumed due to cancer pain (Length of hospitalizations)(at 2 and 4 weeks of observation)