N/A Completed N=71 Randomized Supportive Care

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

Sleep Disorders, Intrinsic · Stage IA Breast Cancer · Stage IB Breast Cancer · Stage II Breast Cancer

Source: ClinicalTrials.gov NCT02002533 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcomePrimary: Percentage of Eligible Patients Consented — 77.17 percentage of participants — p=>0.9999

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eligible Patients Consented	77.17	>0.9999
PRIMARY Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT	73.5	0.7350
PRIMARY Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings	0.8075	<0.0001 sig
SECONDARY Change in Insomnia as Measured by the Insomnia Severity Index (ISI)	-6.259; -2.450	0.1808
SECONDARY Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)	-4.000; -2.750	0.14
SECONDARY Change in Mean Circadian Rhythm Mesor	0.008; -0.046	0.005 sig
SECONDARY Change in Circadian Rhythm Amplitude Over 24 Hours	0.061; -0.164	0.000 sig
SECONDARY Change in Circadian Rhythm Amplitude Over 12 Hours	0.063; 0.127	0.295
SECONDARY Change in Mean Circadian Rhythm Acrophase Over 24 Hours	0.409; -0.912	0.573
SECONDARY Change in Mean Circadian Rhythm Acrophase Over 12 Hours	0.529; 1.516	0.015 sig

Eligibility Criteria

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.)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02002533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.