Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT00993928
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00993928
Study Brief:
Protocol Section:
NCT00993928