Abstract

Objectives: To explore the effect of breakthrough cancer pain (BTcP) treatment on quality of sleep and other aspects of the health-related quality of life (HRQoL) in patients with cancer pain. Methods: In an observational, multicenter, cohort study, cancer patients from palliative care units, oncology departments, and pain clinics and affected by BTcP were included. Enrolled patients were assessed at the four visits: T0 (baseline), T7, T14, and T28. Stable chronic background pain (numeric rating scale, NRS ≤ 4) during the whole study period was mandatory. BTcP was treated through transmucosal fentanyl. Three questionnaires were used to measure the HRQoL: EORTC QLQ-C15-PAL, Pittsburgh Sleep Quality Index (PSQI), and the Edmonton Symptom Assessment System (ESAS). RESULTS: In 154 patients, the HRQoL showed a significant improvement for all physical and emotional characteristics in the EORTC QLQ-C15-PAL, except for nausea and vomiting (linear p-value = 0.1) and dyspnea (Linear p-value = 0.05). The ESAS and PSQI questionnaires confirmed these positive results (p < 0.0001 and p = 0.002, respectively). Conclusions: This prospective investigation by an Italian expert group, has confirmed that careful management of BTcP induces a paramount improvement on the HRQoL. Because in cancer patients there is a high prevalence of BTcP and this severe acute pain has deleterious consequences, this information can have an important clinical significance.

Highlights

  • Pain is one of the most frequent symptoms in cancer patients as it occurs in 20–30% of cases during the initial stages and in up to 75% of patients in advanced disease

  • This study explored the effect of breakthrough cancer pain (BTcP) treatment on several aspects of the health-related quality of life (HRQoL) in patients with cancer pain

  • Despite there is a debate on the starting dose of rapid-onset opioids (ROOs), i.e., if a titration dose is needed or these drugs must be administered in proportional to the regimen of opioid for background pain treatment [16], in this study we have adopted the ROOs administration strategy based on the following the provisions of the relative summary of product characteristics, and in absence of specific contraindications

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Summary

Introduction

Pain is one of the most frequent symptoms in cancer patients as it occurs in 20–30% of cases during the initial stages and in up to 75% of patients in advanced disease. Concerning pain intensity, moderate to severe pain can affect up to 40% of all patients. This symptom strongly affects the patient’s health-related quality of life (HRQoL) and daily activities throughout the cancer disease [1]. In this clinical setting, it is mandatory to relieve pain and other symptoms and to improve the HRQoL at any stage of the disease [2]. Significant results with largest effect size were observed for Global health status/QoL, pain and ESAS (η2p = 0.14; 0.26 and 0.14, respectively)

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