Cognitive-Behavioral Therapy for Chronic Insomnia After Breast Cancer Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The primary goal of the proposed study is to examine a cognitive behavioral intervention for
      insomnia (CBTI) in women after breast cancer treatment. Chronic Insomnia is a highly
      prevalent and distressing symptom in cancer patients. CBTI is considered the treatment of
      choice for chronic primary insomnia. Few studies have been conducted in cancer survivors to
      evaluate the effect of CBTI on sleep and clinically relevant outcomes.
    

Detailed description: 
      The overall goals of this study are to: 1) test standard 4-component CBTI in patients with
      breast cancer post-treatment, 2) gather data on the feasibility of the methods, and 3)
      determine effects of the intervention on quality of life (QOL) and daily functioning. Sixty
      women after completion of primary breast cancer treatment, 21-65 years of age, who meet the
      criteria for chronic insomnia will be recruited from two Western U.S. Cancer Centers.
      Participants will be randomized to one of two treatment conditions (CBTI or behavioral
      placebo treatment). Both groups will receive six in-office and phone sessions. The control
      group will receive the same amount of individualized attention. Sleep efficiency and
      component measures (e.g., sleep onset latency, minutes awake after sleep onset) and quality
      of life and component measures of daily functioning will be assess pre and post-intervention,
      and at 3- and 6-month follow up visits. It is hypothesized that women receiving CBTI
      treatment will demonstrate greater increase in sleep efficiency (time in bed compared with
      time asleep) and will self-report greater improvements in QOL and daily functioning compared
      to those receiving a behavioral placebo treatment at the conclusion of the intervention and
      at 3- to 6-month follow-ups. Established instruments include the Insomnia Severity Index,
      Morin Sleep Diary, Dysfunctional Beliefs and Attitudes about Sleep-16, European Organisation
      for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30, Attentional
      Function Index, Revised Piper Fatigue Scale, and Hospital Anxiety and Depression Scale.
      Subjective data will be corroborated with actigraphy. Results may inform development of
      clinical guidelines for insomnia management after cancer treatment. The proposed study
      associated with this K23 award relates to the Health People 2010 goal of improving quality of
      life of individuals of all ages, and the cancer focus area goal of reducing illness and
      disability caused by cancer.
    

Intervention name(s): Cognitive Behavioral Therapy for Insomnia (CBTI); Behavioral Placebo Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six 15-30 minute in-person or phone sessions that incorporate cognitive, behavioral and psycho-educational techniques focused on modifying the perpetuating factors that maintain insomnia.; Six 15-30 minute in-person or phone sessions that begin with a review of the sleep diary, a general discussion of treatment progress and tabulation of sleep parameters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Breast cancer survivors, insomnia, quality of life