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

NCT02002533 | Completed Results DMC

• 5 other identifiers: URCC12048NCI-2013-01170URCC-12048UG1CA189961U10CA037420
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 6

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• Percentage of Eligible Patients Consented

  Will be evaluated by calculating the specific percentage (with 95% confidence interval) of the total number of participants approached that then consented and enrolled in the study.

  baseline

• Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT

  Will be evaluated by calculating the specific percentage (with 95% confidence interval) and performing an exact binomial test with the null hypothesis being greater than or equal to 75%.

  Up to 1 month

• Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings

  Each NCORP staff person completed a study checklist in which they designated which concepts they discussed with the patient at each session. Concepts included how sleep problems develped, how to control stimulus, and sleeping environment. The overall mean percent delivery was measured using a random effects model (residual maximum likelihood \[REML\] estimation), where the intercept represents the mean delivery and three independent random effects are included. Because of the small sample size, testing will use the Kenward-Roger procedure.

  Up to 1 month

Secondary Outcomes (7)

• Change in Insomnia as Measured by the Insomnia Severity Index (ISI)

  Baseline to up to 1 month

• Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline to up to 1 month

• Change in Mean Circadian Rhythm Mesor

  Baseline to up to 1 month

• Change in Circadian Rhythm Amplitude Over 24 Hours

  baseline to up to 1 month

• Change in Circadian Rhythm Amplitude Over 12 Hours

  baseline to up to 1 month

Study Arms (2)

Arm I (BBT intervention)

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.

Behavioral: Brief Behavioral Therapy; Behavioral: Telephone-Based Intervention

Arm II (control)

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.

Other: Educational Intervention; Behavioral: Telephone-Based Intervention

Interventions

Brief Behavioral Therapy BEHAVIORAL

Undergo BBT intervention

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions

Arm I (BBT intervention)

Telephone-Based Intervention BEHAVIORAL

Undergo BBT intervention

Arm I (BBT intervention)

Educational Intervention OTHER

Undergo HEAL

Also known as: Education for Intervention, Intervention, Educational

Arm II (control)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.)

Sponsors & Collaborators

• Gary Morrow: lead
• National Cancer Institute (NCI): collaborator
• Stanford University: collaborator

Study Sites (6)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Heartland NCORP

Decatur, Illinois, 62526, United States

Location

Wichita NCORP

Wichita, Kansas, 67214, United States

Location

Metro-Minnesota NCORP

Minneapolis, Minnesota, 55426, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Southeast Clinical Oncology Research Program

Winston-Salem, North Carolina, 27104, United States

Location

Related Publications (1)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Breast Neoplasms

Interventions

Behavior Therapy; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Results Point of Contact

• Title: Gary Morrow
• Organization: University of Rochester

gary_morrow@urmc.rochester.edu

585-275-9961

Study Officials

• Oxana Palesh

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 30, 2013
• First Posted: December 6, 2013
• Study Start: February 3, 2014
• Primary Completion: December 16, 2016
• Study Completion: December 16, 2016
• Last Updated: June 5, 2019
• Results First Posted: December 2, 2017

Record last verified: 2019-06

Locations

US (6)