Status:
TERMINATED
Home-Based Programs for Improving Sleep in Cancer Survivors
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Cancer Survivor
Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 i...
Detailed Description
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 slee...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00993928
Start Date
April 1 2010
End Date
May 1 2019
Last Update
December 3 2019
Active Locations (193)
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1
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
2
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
3
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
4
Florida Hospital - Orlando
Orlando, Florida, United States, 32803