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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Rochester
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT02002533
First received: November 30, 2013
Last updated: October 31, 2014
Last verified: October 2014
  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.


Condition Intervention Phase
Sleep Disorders
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Behavioral: BBT Intervention
Behavioral: Healthy Eating Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Proportion of eligible patients consented [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    Will be evaluated by calculating the specific proportion (with 95% confidence interval) and performing an exact binomial test with the null hypothesis being P0=0.40, 0.75.

  • Proportion of consented participants who complete the study, defined as completion of at least 5 BBT sessions [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    Will be evaluated by calculating the specific proportion (with 95% confidence interval) and performing an exact binomial test with the null hypothesis being P0=0.40, 0.75.

  • Percentage of key components delivered by NCORP staff, assessed by checklist and auditing of audio-recordings [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
    Will be evaluated by calculating and testing the overall mean percent delivery 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.


Secondary Outcome Measures:
  • Change in insomnia as measured by the ISI [ Time Frame: Baseline to up to 1 month ] [ Designated as safety issue: No ]
    The difference between arms will be assessed using analysis of covariance (ANCOVA). The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported.

  • Change in sleep quality as measured by the PSQI [ Time Frame: Baseline to up to 1 month ] [ Designated as safety issue: No ]
    The difference between arms will be assessed using ANCOVA. The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported.

  • 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 ] [ Designated as safety issue: No ]
    The difference between arms will be assessed using ANCOVA. The response will be the post-intervention outcome. Arm will be the factor, and baseline will be the covariate. Appropriate contrasts will be used to estimate the difference between arms in change from baseline. Initially, the arm*baseline interaction will be assessed with an F test. If this interaction is insignificant at the 0.05 level, it will be dropped from the final model. If the interaction is significant, then mean change from baseline at various levels of baseline will be reported.


Estimated Enrollment: 70
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBT intervention
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 2 or 3, and four 15 minute telephone sessions in weeks 2, 3, 5, and 6 or 2, 4, 5, and 6.
Behavioral: BBT Intervention
Undergo BBT intervention
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
Active Comparator: Healthy Eating Education
Patients undergo Healthy Eating Education 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.
Behavioral: Healthy Eating Intervention
Undergo healthy eating intervention
Other Names:
  • Behavior Therapy
  • Behavioral Modification
  • Behavioral Treatment

Detailed 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 Community Clinical Oncology Program (CCOP) 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.

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 2 or 3, 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002533

Locations
United States, California
Stanford University Medical Center Active, not recruiting
Stanford, California, United States, 94305
United States, Illinois
Heartland NCORP Recruiting
Decatur, Illinois, United States, 62526
Contact: James L Wade, MD    217-876-6618    jlwade3@sbcglobal.net   
Contact: Peggy Wisher    217-876-4755    pwisher@dmhhs.org   
United States, Kansas
Wichita NCORP Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD    316-262-4467      
Contact: Keisha Humphries    316-268-5374    keisha.humphries@viachristi.org   
United States, Minnesota
Metro Minnesota NCORP Recruiting
Minneapolis, Minnesota, United States, 55426
Contact: Joseph Leach, MD    952-993-1517    Joseph.leach@allina.com   
Contact: Charlotte Coles    952-993-1576    Charlotte.Coles@parknicollet.com   
United States, New York
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Southeast Clinical Oncology Research Consortium Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: James N. Atkins, MD    336-777-3036    jnatkins@juno.com   
Contact: Susan Tuttle    336-777-3036    stuttle@wakehealth.edu   
Sponsors and Collaborators
Gary Morrow
Investigators
Principal Investigator: Oxana Palesh Stanford University
  More Information

No publications provided

Responsible Party: Gary Morrow, Director, URCC / University of Rochester NCORP Reseach Base, University of Rochester
ClinicalTrials.gov Identifier: NCT02002533     History of Changes
Other Study ID Numbers: URCC12048, NCI-2013-01170, URCC12048, URCC-12048, U10CA037420
Study First Received: November 30, 2013
Last Updated: October 31, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Parasomnias
Sleep Disorders
Breast Neoplasms
Disease
Breast Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014