Management of Insomnia in Breast Cancer Patients
Condition: Insomnia; Fatigue
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: BBT-I; Control; Armodafinil
Intervention description: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone; Control behavioral intervention is a sleep hygiene handout completed by participant.; 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I)
      on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

      Participants will be randomized into 4 groups:

        -  Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.

        -  Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.

        -  Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical
           intervention.

        -  Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy
             and/or diagnosis of metastatic breast are allowed)

          -  Have at least 6 weeks of treatment remaining

          -  ≥ 21 years old

          -  Able to understand written and spoken English

          -  Able to swallow medication (until amendment omitting armodafinil treatment)

          -  Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia
             Severity Index (ISI)

        EXCLUSION CRITERIA

          -  Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil
             treatment)

          -  Prior treatment with psycho-stimulant medication within the past 28 days (until
             amendment omitting armodafinil treatment)

          -  Prior treatment with antiseizure medications (until amendment omitting armodafinil
             treatment)

          -  Has continuously taken sleep medication daily for the last 28 days (until amendment
             omitting armodafinil treatment)

          -  History (self-reported) of unstable medical or psychiatric illness (within the last 5
             years)

          -  History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or
             seizures (until amendment omitting armodafinil treatment)

          -  Pregnant or nursing

          -  History of substance abuse or meet criteria for current alcohol abuse or dependence

          -  History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg
             syndrome (RLS)

          -  Severe hepatic impairment (until amendment omitting armodafinil treatment)