Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Trial ID or NCT#
NCT02002533
Status
RECRUITING
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 Criteria
Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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.)
Contact us to find out if this trial is right for you.
Contact
Oxana Palesh
650-725-7011
View on ClinicalTrials.gov
