Palo Alto, California 94305


Purpose:

PRIMARY OBJECTIVE(S): The purpose of this study is to test the efficacy of brief behavioral therapy versus control condition that accounts for time and attention (nutrition education) in the treatment of insomnia in humans. SECONDARY OBJECTIVE(S): To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes


Criteria:

Inclusion Criteria: - Be female and have a diagnosis of Breast Cancer (Stage I-IIIA). - Be scheduled for planned cancer treatment (e.g. chemotherapy or biologics such as herceptin). - Have at least 6 weeks of cancer treatment (e.g. chemotherapy or biologics such as herceptin) remaining. - Be at least 21 years of age. - Be able to understand written and spoken English. - Report sleep disturbance of 8 or greater on the ISI, and report insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy (to exclude pre-existing, chronic insomnia). - Have a Karnofsky score >= 70 to ensure that patients are able to participate in intervention and assessments. 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 (patients are monitored for pregnancy during chemotherapy and pregnant women in the first trimester are not administered chemotherapy. Therefore, pregnancy status of women will be known prior to the entrance to the study). - Have a history of substance abuse or meet criteria for current alcohol abuse or dependence - Have a self-reported history 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 - Are unable or unwilling to discontinue anxiolytics within 4 hours of education sessions - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)


NCT ID:

NCT02165839


Primary Contact:

Principal Investigator
Oxana Palesh, PhD
Stanford University

Bingjie Tong
Email: tbingjie@stanford.edu


Backup Contact:

N/A


Location Contact:

Palo Alto, California 94305
United States

Bingjie Tong
Email: tbingjie@stanford.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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