title: 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 < .001), symptom burden (P < .001), and overall mood disturbance (P < .001) than good sleepers. Also, compared with good sleepers, poor sleepers had greater fatigue-related and symptom-related interference with daily activities (all P values < .001). The MDASI disturbed-sleep item correlated well with the global PSQI score (Pearson's r = 0.679, P < .001), and this suggests its usefulness as a patient-reported outcome screener of sleep quality in early-phase clinical trials clinics.
  
  
  CONCLUSIONS
  Poor sleep quality was a significant problem in the current study and was associated with greater fatigue, symptom burden, and mood disturbance. Sleep quality should be routinely assessed in patients with advanced cancer who are participating in early-phase clinical trials. Cancer 2016;122:3401-3409. © 2016 American Cancer Society.
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas. ggeorge2@mdanderson.org.|Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas. ggeorge2@mdanderson.org.
authors.forename: Goldy C
authors.initials: GC
authors.lastname: George
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Eucharia C
authors.initials: EC
authors.lastname: Iwuanyanwu
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Karen O
authors.initials: KO
authors.lastname: Anderson
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Alizeh
authors.initials: A
authors.lastname: Yusuf
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Ralph G
authors.initials: RG
authors.lastname: Zinner
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Sarina A
authors.initials: SA
authors.lastname: Piha-Paul
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Apostolia M
authors.initials: AM
authors.lastname: Tsimberidou
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Aung
authors.initials: A
authors.lastname: Naing
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Siqing
authors.initials: S
authors.lastname: Fu
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Filip
authors.initials: F
authors.lastname: Janku
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Vivek
authors.initials: V
authors.lastname: Subbiah
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Charles S
authors.initials: CS
authors.lastname: Cleeland
authors.affiliation: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: Tito R
authors.initials: TR
authors.lastname: Mendoza
authors.affiliation: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic; D005221:Fatigue / Q000209:etiology* / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000209:etiology* / Q000473:pathology; D009369:Neoplasms / Q000503:physiopathology*; D015995:Prevalence; D011379:Prognosis; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000150:complications / Q000453:epidemiology*; D011795:Surveys and Questionnaires; D013781:Texas / Q000453:epidemiology; D055815:Young Adult
keywords: clinical trials; fatigue; mood; patients with advanced cancer; sleep quality; symptom burden