Overview

This trial is active, not recruiting.

Conditions 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
Treatments brief behavioral therapy, telephone-based intervention, educational intervention
Phase phase 2
Sponsor Gary Morrow
Collaborator National Cancer Institute (NCI)
Start date February 2014
End date September 2016
Trial size 71 participants
Trial identifier NCT02002533, NCI-2013-01170, U10CA037420, UG1CA189961, URCC-12048, URCC12048

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.

United States Kansas, Minnesota, New York, and North Dakota
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.
brief behavioral therapy Behavior Conditioning Therapy
Undergo BBT intervention
telephone-based intervention
Undergo BBT intervention
(Active Comparator)
Patients undergo HEAL comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.
educational intervention Education for Intervention
Undergo HEAL
telephone-based intervention
Undergo HEAL

Primary Outcomes

Measure
Proportion of eligible patients consented
time frame: Up to 1 month
Proportion of consented participants who complete the study, defined as completion of at least 5 BBT or 5 HEAL sessions
time frame: Up to 1 month
Percentage of key components of BBT delivered by NCORP staff, assessed by checklist and auditing of audio-recordings
time frame: Up to 1 month

Secondary Outcomes

Measure
Change in insomnia as measured by the ISI
time frame: Baseline to up to 1 month
Change in sleep quality as measured by the PSQI
time frame: Baseline to up to 1 month
Change in circadian rhythm as measured by the two-oscillator cosinor parameter estimates based on actigraphy data
time frame: Baseline to up to 1 month
Change in HRV as measured by the ambulatory monitoring heart-rate device Firstbeat® Bodyguard 2
time frame: Baseline to up to 1 month

Eligibility Criteria

Female participants at least 21 years old.

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.)

Additional Information

Official title Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial
Principal investigator Oxana Palesh
Description PRIMARY OBJECTIVES: I. Determine recruitment rates to the proposed randomized controlled trial (RCT). II. Determine the rate of intervention adherence. III. Determine the feasibility of training National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical research staff to successfully deliver the Brief Behavioral Therapy (BBT) intervention. SECONDARY OBJECTIVES: I. Obtain preliminary estimates for the effect of the intervention (compared with control) on insomnia as measured by the Insomnia Severity Index (ISI). II. Obtain preliminary estimates for the effect of the intervention (compared with control) on sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI). III. Obtain preliminary estimates for the effect of the intervention (compared with control) on circadian rhythm as measured by the two-oscillator cosinor parameter estimates based on actigraphy data. IV. Obtain preliminary estimates for the effect of the intervention (compared with control) on heart rate variability (HRV) as measured by the Firstbeat® ambulatory heart-rate monitor (i.e., 1. respiratory sinus arrhythmia-RSA, 2. standard deviation of all normal R-wave to R-wave intervals--SDNN, 3. root mean square of successive differences between adjacent normal R-wave to R-wave intervals--RMSSD, 4. The ratio of low frequency total spectrum power of all NN intervals between .04 to .15 Hertz to high frequency total spectrum power of all NN intervals between .15 to .40 Hertz--LF/HF ratio, and 5. natural log of low frequency total spectrum power of all NN intervals between 0.04 to 0.15Hz.). TERTIARY OBJECTIVES: I. Obtain preliminary estimates for the effect of the intervention (compared with control) on quality of life as measured by the Functional Assessment of Chronic Illness Therapy (FACIT) total score and subscales. II. Obtain preliminary estimates for the effect of the intervention (compared with control) on general mood as measured by the Profile of Mood States (POMS) total score and subscales. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo BBT intervention, comprising insomnia education, stimulus control, discouragement of napping and encouragement of exercise, and sleep compression over two 60 minute face-to-face sessions in weeks 1 and 3 or 4, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6. ARM II: Patients undergo Healthy Eating Education (HEAL) comprising nutritional education and suggestions for symptom management over two 60 minute face-to-face sessions in weeks 1 and 2 or 3, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6. After completion of study, patients are followed up at 1 month.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Rochester.