Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a clinic for early-phase oncology clinical trials

Abstract

BACKGROUND: Limited data exist about sleep quality for patients with advanced cancer in phase 1 clinical trials. Poor sleep quality is often not captured as an adverse event, and its association with fatigue, one of the most frequently reported adverse events, is not documented routinely. This article describes sleep quality and its relation with fatigue, symptom burden, and mood in patients recruited from an early-phase clinic for targeted therapy. METHODS: Sleep, fatigue, symptom burden, and mood were assessed with the Pittsburgh Sleep Quality Index (PSQI), the Brief Fatigue Inventory, the MD Anderson Symptom Inventory (MDASI), and the Brief Profile of Mood States, respectively; the Eastern Cooperative Oncology Group (ECOG) performance status (PS) was determined from medical records. RESULTS: The sample (n = 256) was 51.2% female, 90% had an ECOG PS of 0 or 1, and the mean age was 58 ± 0.8 years. Poor sleepers (global PSQI score > 5) constituted 64% of the sample. In separate multiple regression models, poor sleepers had higher levels of fatigue (P