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Brief Behavioral Intervention for Insomnia During Chemotherapy
Not Recruiting
Trial ID: NCT02165839
Purpose
PRIMARY OBJECTIVE(S):
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
Official Title
Brief Behavioral Intervention for Insomnia During Chemotherapy
Stanford Investigator(s)
Clete A. Kushida, MD, PhD
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)
Eligibility
INCLUSION CRITERIA
- Female
- 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
- Have an unstable self-reported medical or psychiatric illness (Axis I - current or
within the last 5 years).
- 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)
Intervention(s):
behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
behavioral: Healthy Eating Education Learning (HEAL)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Oxana Palesh
650-725-7011