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Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Recruiting
I'm InterestedTrial ID: NCT02002533
Purpose
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.
Official Title
Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial
Eligibility
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
permitted
- 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.)
Intervention(s):
behavioral: Brief Behavioral Therapy
behavioral: Telephone-Based Intervention
other: Educational Intervention
behavioral: Telephone-Based Intervention
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Oxana Palesh
650-725-7011