Brief Behavioral Intervention for Insomnia During Chemotherapy
NCT ID: NCT02165839
Last Updated: 2020-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
139 participants
INTERVENTIONAL
2015-01-31
2020-06-30
Brief Summary
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To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.
SECONDARY OBJECTIVE(S):
* To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.
* To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Healthy Eating Education Learning (HEAL)
Control group.
Healthy Eating Education Learning (HEAL)
Brief Behavioral Therapy for Insomnia (BBT-I)
Brief Behavioral Therapy for Insomnia (BBT-I)
Interventions
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Brief Behavioral Therapy for Insomnia (BBT-I)
Healthy Eating Education Learning (HEAL)
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Breast Cancer (Stage I-IIIA)
* Scheduled for planned cancer treatment (eg, chemotherapy or biologic agents), or treatment is continuing
* Has ≥ 6 weeks of cancer treatment (eg, chemotherapy or biologic agents) remaining
* ≥ 21 years of age.
* Able to understand written and spoken English.
* Sleep disturbance of 8 or greater on the ISI, and insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy (to exclude pre-existing, chronic insomnia).
* Karnofsky score ≥ 70
Exclusion Criteria
* Be currently pregnant or nursing
* History of substance abuse or meet criteria for current alcohol abuse or dependence
* History (self-reported) of sleep apnea or restless leg syndrome (RLS)
* Self-report or have a medical record of an unstable comorbid medical or psychiatric condition that would make it unsafe or impossible to adhere to the study protocol
* Unable or unwilling to discontinue anxiolytics within 4 hours of education sessions
* Irregular heartbeat or arrhythmia (self-reported or in the medical record)
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
Oxana Palesh PhD, MPH
Principal Investigators
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Oxana Palesh, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University, School of Medicine
Palo Alto, California, United States
Countries
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References
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Woldeamanuel YW, Blayney DW, Jo B, Fisher SE, Benedict C, Oakley-Girvan I, Kesler SR, Palesh O. Headache outcomes of a sleep behavioral intervention in breast cancer survivors: Secondary analysis of a randomized clinical trial. Cancer. 2021 Dec 1;127(23):4492-4503. doi: 10.1002/cncr.33844. Epub 2021 Aug 6.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BRS0042
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-30470
Identifier Type: -
Identifier Source: org_study_id