Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2011-01-31
2016-07-31
Brief Summary
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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.
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Detailed Description
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Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.
Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.
Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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BBT-I + Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
Armodafinil 150 mg/day by mouth.
BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Behavioral placebo + Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth.
Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
BBT-I without Armodafinil
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention.
BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Behavioral placebo without Armodafinil
Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention.
Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Interventions
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BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
21 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
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Oxana Palesh
Assistant Professor of Psychiatry and Behavioral Sciences
Principal Investigators
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Oxana RG Palesh, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Other Identifiers
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25740
Identifier Type: OTHER
Identifier Source: secondary_id
BRS0008
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-17323
Identifier Type: -
Identifier Source: org_study_id
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