title: Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial.
abstract: OBJECTIVE
  Cancer-related insomnia is associated with diminished quality of life (QOL), suggesting that improvement in insomnia may improve QOL in cancer survivors. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia, but less is known regarding its effect on QOL and whether improvement in insomnia corresponds to improved QOL. The present analysis examines the effects of CBT-I, with and without armodafinil, on QOL both directly and indirectly through improvements of insomnia.
  
  
  METHODS
  This is an analysis of 95 cancer survivors for a specified secondary aim of a four-arm randomized controlled trial assessing the combined and individual effects of CBT-I and armodafinil to improve insomnia. QOL and insomnia severity were assessed before, during the intervention, at post-intervention, and 3 months later by Functional Assessment of Cancer Therapy-General and Insomnia Severity Index, respectively.
  
  
  RESULTS
  Mean change in QOL from pre- to post-intervention for CBT-I + placebo, CBT-I + armodafinil, armodafinil, and placebo was 9.6 (SE = 1.8; p < 0.0001), 11.6 (SE = 1.8; p < 0.0001), -0.2 (SE = 3.2; p = 0.964), and 3.3 (SE = 2.0; p = 0.124), respectively. ANCOVA controlling for pre-intervention scores showed that participants receiving CBT-I had significantly improved QOL at post-intervention compared to those not receiving CBT-I (p < 0.0001, effect size = 0.57), with benefits being maintained at the 3-month follow-up. Path analysis revealed that this improvement in QOL was due to improvement in insomnia severity (p = 0.002), and Pearson correlations showed that changes in QOL from pre- to post-intervention were significantly associated with concurrent changes in insomnia severity (r = -0.56; p < 0.0001). Armodafinil had no effect on QOL for those who did or did not receive it (p = 0.976; effect size = -0.004).
  
  
  CONCLUSIONS
  In cancer survivors with insomnia, CBT-I resulted in clinically significant improvement in QOL via improvement in insomnia. This improvement in QOL remained stable even 3 months after completing CBT-I.
  
  
  CONCLUSIONS
  Considering the high prevalence of insomnia and its detrimental impact on QOL in cancer survivors and the effectiveness of CBT-I in alleviating insomnia, it is important that evidence-based non-pharmacological sleep interventions such as CBT-I be provided as an integral part of cancer care.
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA. Anita_Peoples@urmc.rochester.edu.
authors.forename: Anita R
authors.initials: AR
authors.lastname: Peoples
authors.affiliation: Departments of Psychology and Oncology, Memorial University, Newfoundland, Canada.
authors.forename: Sheila N
authors.initials: SN
authors.lastname: Garland
authors.affiliation: Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 670, Philadelphia, PA, 19104, USA.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Perlis
authors.affiliation: School of Psychology, Laval University, Quebec City, QC, Canada.
authors.forename: Josée
authors.initials: J
authors.lastname: Savard
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Charles E
authors.initials: CE
authors.lastname: Heckler
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Charles S
authors.initials: CS
authors.lastname: Kamen
authors.affiliation: Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Rochester, NY, 14642, USA.
authors.forename: Julie L
authors.initials: JL
authors.lastname: Ryan
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Karen M
authors.initials: KM
authors.lastname: Mustian
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Michelle C
authors.initials: MC
authors.lastname: Janelsins
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Luke J
authors.initials: LJ
authors.lastname: Peppone
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Gary R
authors.initials: GR
authors.lastname: Morrow
authors.affiliation: Department of Surgery, University of Rochester Medical Center, 265 Crittenden Blvd., CU 420658, Rochester, NY, 14642-0658, USA.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Roscoe
mesh_terms: D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009369:Neoplasms / Q000150:complications* / Q000401:mortality; D011788:Quality of Life / Q000523:psychology*; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D017741:Survivors; D016896:Treatment Outcome; D064690:Wakefulness-Promoting Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D001559:Benzhydryl Compounds; D064690:Wakefulness-Promoting Agents; D000077408:Modafinil
keywords: CBT-I; Cancer; Cancer survivors; Insomnia; Quality of life