Trial Search Results

Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy

This randomized phase II trial studies how well brief behavioral therapy works in improving sleep disorders in patients with stage I-III breast cancer undergoing chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia as well as improve the well-being and quality of life in patients with breast cancer who are undergoing chemotherapy.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Gary Morrow

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Behavioral: Brief Behavioral Therapy
  • Behavioral: Telephone-Based Intervention
  • Other: Educational Intervention
  • Behavioral: Telephone-Based Intervention




Inclusion Criteria:

   - Newly diagnosed breast cancer (stage I, II, III)

   - Be receiving chemotherapy in either weekly, 2-week or 3-week cycles and have at least
   6 weeks of chemotherapy treatment remaining; patients are eligible any time before
   chemotherapy cycle 3 if on a 2- or 3-week cycle, or cycle 4 if on a 1-week cycle;
   (Note: use of biologics [e.g., Herceptin (trastuzumab)] is permitted)

      - For patients on a weekly regimen, there should be at least 3 dosages of
      chemotherapy remaining

      - For patients on either a 2 week or 3 week cycle, there should be at least 2
      dosages of chemotherapy remaining

      - Patients will not be dropped from the study if their chemotherapy is discontinued
      after they are enrolled

   - Report sleep disturbance of 8 (sum total of all 7 items) or greater on the Insomnia
   Severity Index

      - (Note: this measure will be repeated again at baseline assessment)

   - Report sleep problems that began or got worse with the diagnosis of cancer or with
   chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer
   or with chemotherapy?)

   - Be able to speak and read English

   - Patients can take sleep aids (e.g., hypnotics and sedatives) for insomnia if they use
   sleep aids as needed; patients taking sleep aids every night are excluded; use of
   melatonin every night is permitted and these patients are not excluded

   - Be able and willing to wear an Actiwatch for the entire 24 hours of each day they are
   scheduled to wear it

Exclusion Criteria:

   - Have diagnosis of breast cancer stage IV

   - Have sleep problems that began before diagnosis and have not changed since diagnosis

   - 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

   - Have a clinical diagnosis of sleep apnea or restless leg syndrome

   - Be unable or unwilling to discontinue anxiolytic medication within 4 hours of
   intervention sessions

   - Take medication for sleep (e.g., hypnotics and sedatives) every night; melatonin is

   - Patients who are shift workers are excluded; shift worker is defined as someone who
   has irregular work and sleep hours (such as working a non-traditional schedule: e.g.,
   4pm-midnight or 10pm-6am; a rotating schedule e.g., alternating between day and night
   shifts, or starting work between 4am and 7am)

   - Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left
   ventricular assist device, etc.)

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study


Now accepting new patients

Contact Information

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