Home-Based Programs for Improving Sleep in Cancer Survivors
Condition: Cancer Survivor; Fatigue; Psychosocial Effects of Cancer and Its Treatment; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Fatigue
Intervention: Home-based sleep intervention
Intervention description: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psychosocial effects of cancer and its treatment; fatigue; sleep disorders; cancer survivor

Summary:

      RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may
      help improve the sleep of cancer survivors. It is not yet known which home-based program is
      more effective in improving the sleep of cancer survivors.

      PURPOSE: This randomized phase II trial is comparing two home-based programs for improving
      sleep in cancer survivors.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Prior diagnosis of cancer

          -  At least 2 months and ≤ 24 months since completed curative-intent treatment
             (chemotherapy, surgery, and/or radiotherapy)

               -  Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex)

               -  Concurrent trastuzumab and maintenance rituximab allowed

          -  Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7
             nights in a week and wishing therapeutic intervention, and/or self report of waking up
             after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on
             3 out of 7 nights in a week

          -  No history of diagnosis of primary insomnia (patient medical record, defined by having
             had behavioral, cognitive, or pharmacologic treatment) for > 30 consecutive days in
             the year before cancer diagnosis

          -  No active cancer (i.e., not considered no evidence of disease)

          -  No concurrent CNS malignancy

          -  No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs,
             or periodic leg movement disorder)

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Availability of a CD player and head or earphones

          -  Ability to complete questionnaires

          -  No uncontrolled chronic pain (i.e., pain score of ≥ 4 on Numeric Analogue Sleep and
             Pain Scale)

          -  No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia
             per medical record

          -  No hot flashes that interrupt sleep

          -  Not working overnight hours and unable to change schedule

          -  No emotional, psychological, or physical state that, according to physician and/or
             study personnel evaluation, would preclude adherence to daily home intervention
             implementation

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  More than 4 days since prior corticosteroid, including inhaled steroids, of any dose
             for > 2 days

          -  No prior experience with guided imagery or cognitive behavioral therapy for insomnia

          -  No concurrent new herbal therapies

               -  Stable dose of daily herbal supplements started ≥ 8 weeks before study
                  intervention allowed

               -  Herbal teas or herbs in various drink products allowed

          -  No concurrent treatment with variable doses of any of the following:

               -  Antidepressants

               -  Anxiolytics

               -  Pain medication (not including over the counter ad anti-inflammatory pain
                  relievers)

          -  Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4
             weeks before study entry, and can be used daily or intermittently