title: CHoosing Options for Insomnia in Cancer Effectively (CHOICE): Design of a patient centered comparative effectiveness trial of acupuncture and cognitive behavior therapy for insomnia.
abstract: Insomnia is a prevalent and persistent side effect of cancer, which if left unaddressed, can be unremitting and negatively influence physical and mental well-being. Acupuncture and Cognitive Behavioral Therapy (CBT) are commonly used non-pharmacological treatments that are efficacious for treating insomnia in cancer patients; however, little is known about the comparative effectiveness of these options. The goal of personalized medicine is to determine which treatments are most effective for which individuals, and patient preference for treatment is a particularly important contributor to adherence and outcomes. Here we describe the design of a clinical trial that begins to determine how best to personalize the treatment of insomnia for cancer survivors. This project is a randomized controlled comparative effectiveness trial with a nested qualitative study comparing acupuncture and CBT for insomnia and co-morbid symptoms in a heterogeneous sample of 160 cancer survivors. The primary aim is to determine which treatment is associated with the largest reduction in insomnia severity. The secondary aim is to examine the demographic, clinical, and psychological characteristics that predict and/or moderate treatment effect. Patients will receive ten treatments of acupuncture or 7 sessions of CBT over eight weeks and complete validated patient-reported outcome measures of sleep and co-morbid symptoms at baseline, mid-treatment, post-treatment, and at three-months to assess durability of effect. The results of the proposed study have the potential to improve healthcare outcomes by helping cancer survivors and their caregivers make informed and evidence-based decisions, leading to patient-centered and personalized care for cancer survivors with insomnia.
authors.affiliation: Department of Psychology, Memorial University of Newfoundland, St. John's, NL, Canada.
authors.forename: Sheila N
authors.initials: SN
authors.lastname: Garland
authors.affiliation: Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.
authors.forename: Philip
authors.initials: P
authors.lastname: Gehrman
authors.affiliation: Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.
authors.forename: Frances K
authors.initials: FK
authors.lastname: Barg
authors.affiliation: Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, United States.
authors.forename: Sharon X
authors.initials: SX
authors.lastname: Xie
authors.affiliation: The Bendheim Center for Integrative Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, United States. Electronic address: maoj@mskcc.org.
authors.forename: Jun J
authors.initials: JJ
authors.lastname: Mao
mesh_terms: D015670:Acupuncture Therapy; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D057186:Comparative Effectiveness Research / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D012107:Research Design; D007319:Sleep Initiation and Maintenance Disorders / Q000209:etiology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Acupuncture; Cancer; Cognitive Behavior Therapy; Comparative effectiveness; Insomnia; Randomized controlled trial