Trial record 7 of 571 for:    Open Studies | "Sleep Disorders"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of Rochester
Sponsor:
Collaborators:
Stanford University
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT02002533
First received: November 30, 2013
Last updated: June 1, 2015
Last verified: June 2015
  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 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
Behavioral: Brief Behavioral Therapy
Behavioral: Telephone-Based Intervention
Other: Educational 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 or 5 HEAL 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 of BBT 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.

  • Change in HRV as measured by the ambulatory monitoring heart-rate device Firstbeat® Bodyguard 2 [ Time Frame: Baseline to up to 1 month ] [ Designated as safety issue: No ]
    Five outcomes will be assessed. Two time domains will be assessed including SDNN and RMSSD. Three frequency domains will be assessed including RSA, LF, and LF/HF ratio. Will assess the difference between arms in mean post-intervention - baseline using ANCOVA. 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.


Other Outcome Measures:
  • Change in quality-of-life measured by the FACT-B [ 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 general mood measured by the POMS [ 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: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (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 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
Undergo BBT intervention
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
Behavioral: Telephone-Based Intervention
Undergo BBT intervention
Active Comparator: Arm II (control)
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
Undergo HEAL
Other Names:
  • Education for Intervention
  • Intervention, Educational
Behavioral: Telephone-Based Intervention
Undergo HEAL

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 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.

  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)
  • Have an implanted device for heart failure (e.g., pacemaker, defibrillator, left ventricular assist device, etc.)
  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 Not yet recruiting
Stanford, California, United States, 94305
Contact: Oxana Palesh    650-725-7011    opalesh@stanford.edu   
Principal Investigator: Oxana Palesh         
United States, Illinois
Heartland NCORP Recruiting
Decatur, Illinois, United States, 62526
Contact: Peggy Wisher    217-876-6618    pwisher@dmhhs.org   
United States, Kansas
Wichita NCORP Recruiting
Wichita, Kansas, United States, 67214
Contact: Keisha Humphries    316-268-5374    keisha.humphries@viachristi.org   
United States, Minnesota
Metro-Minnesota NCORP Recruiting
Minneapolis, Minnesota, United States, 55426
Contact: Michelle Lacey    952-993-1517    michele.lacey@parknicollet.com   
United States, New York
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
Contact: Karen Mustian    585-275-5513    Karen_mustian@urmc.rochester.edu   
Principal Investigator: Karen Mustian         
United States, North Carolina
Southeast Clinical Oncology Research Program Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Robin Burgess, RN    336-777-3036    rburgess@southeastclinicaloncology.org   
Sponsors and Collaborators
Gary Morrow
Stanford University
Investigators
Principal Investigator: Oxana Palesh University of Rochester NCORP Research Base
  More Information

No publications provided

Responsible Party: Gary Morrow, Director, University of Rochester NCORP Research Base, University of Rochester
ClinicalTrials.gov Identifier: NCT02002533     History of Changes
Other Study ID Numbers: URCC12048, NCI-2013-01170, URCC12048, URCC-12048, URCC12048, UG1CA189961, U10CA037420
Study First Received: November 30, 2013
Last Updated: June 1, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 01, 2015