Trial Search Results

Brief Behavioral Intervention for Insomnia During Chemotherapy


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.


To assess the impact of different biomarkers on sleep disruption and other patient reported outcomes

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University


  • Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)
  • Behavioral: Healthy Eating Education Learning (HEAL)




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

   - 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

   - 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

   - Have irregular heartbeats or arrhythmia (self-reported or in the medical record)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Oxana Palesh