| Conditions: |
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Cancer Survivor - Fatigue - Psychosocial Effects of Cancer and Its Treatment - Sleep Disorders |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake
disturbances,as measured by sleep latency or time to fall back asleep after initial
sleep onset per sleep diaries, at baseline (week 1) and at the end of week 7 in cancer
survivors.
Secondary
- To compare the efficacy of these interventions as therapy for sleep-wake disturbances
as measured by the number of awakenings after sleep, sleep quality, sleep difficulty,
and sleep latency at baseline (week 1) and weeks 4 and 7 in these participants.
- To compare the efficacy of these interventions as therapy for sleep-wake disturbances
as measured by the percentage of participants in each group who show improved sleep per
the Pittsburgh Sleep Quality Index.
- To compare the effects of these interventions on fatigue, mood disturbance, sleep,
benefit, and distress in this patient population.
- To describe the side effects associated with these interventions in these patients.
- To describe patient practice habits and adherence measured via a practice diary.
- To explore symptom clusters in this patient population and look at distress as a
mediating variable. (Exploratory)
- To explore predictors of sleep quality. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to current (≥ 1 per
week in the past 4 weeks) pharmacological treatment, including anxiolytics, for insomnia or
mood (yes vs no), current pharmacologic treatment for pain (yes vs no), sleep difficulty
period (≤ 1 month vs > 1 month), and age (≤ 50 vs 51-70 vs > 70 years). Patients are
randomized to 1 of 2 intervention groups.
- Group 1: Participants receive a home-based sleep intervention comprising a Sleep
Hygiene Education booklet, printed stimulus-control guidelines, instructions on
sleeping restrictions, and a guided-imagery pre-recorded mp3 device. Participants meet
with study personnel for intervention refinement and are asked to practice behaviors
consistent with the stimulus-control sheet, to read the sleep hygiene booklet one
chapter per day for 7 days during the first week, and then as needed during study. They
are also instructed to use the CD, with or without headphones, in a quiet and
comfortable place without lights for up to 30 minutes every day for 6 weeks before
bedtime. Participants are instructed to go to sleep and wake at the same time every day
during study intervention.
- Group 2: Participants receive a home-based sleep intervention comprising a Sleep
Hygiene Education booklet, printed stimulus-control guidelines, and a pre-recorded mp3
device containing short stories and essays. Participants meet with study personnel and
are instructed to practice behaviors consistent with the stimulus control sheet, to
read the sleep hygiene booklet, and use the CD as in group 1. Participants are not
instructed about sleeping restrictions. They are offered the guided-imagery CD after
study completion.
Patients complete a Three-Day Sleep Diary for 3 consecutive days at baseline and during
weeks 4 and 7 of study intervention. Patients also complete questionnaires on Numeric Analog
Sleep for Pain Scale, daily use of CD, Sleep Hygiene Practice, Pittsburgh Sleep Quality
Index, Profile of Mood States, Brief Fatigue Inventory, Distress Thermometer, Side-Effect
Questionnaire, and a Subject Global Impression of Change at baseline, during weeks 2 and 6,
and after completion of study intervention.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Prior diagnosis of cancer
- At least 2 months and ≤ 24 months since completed curative-intent treatment
(chemotherapy, surgery, and/or radiotherapy)
- Concurrent hormonal therapy (e.g., tamoxifen or aromatase inhibitors) allowed
- 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)
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| NCT ID: |
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NCT00993928 |
| Primary Contact: |
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Study Chair
Debra Barton, RN, PhD, AOCN, FAAN
Mayo Clinic
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| Backup Contact: |
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N/A |
| Location Contact: |
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Plymouth, Indiana 46563
United States
Michael W. Method, MD, MPH
Phone: 574-237-1328
Site Status: Recruiting |