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

Completed · Not applicable

Conditions studied: Sleep Disorder, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

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.

Key facts

Study ID: NCT02002533
Run by: Gary Morrow
People needed: 71
Starts: 2014-02-03
Expected to finish: 2016-12-16
Last updated by the study team: 2019-06-05

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.)

Where it is running

Stanford University Medical Center — Stanford, California, United States
Heartland NCORP — Decatur, Illinois, United States
Wichita NCORP — Wichita, Kansas, United States
Metro-Minnesota NCORP — Minneapolis, Minnesota, United States
University of Rochester — Rochester, New York, United States
Southeast Clinical Oncology Research Program — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.