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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02002533
First Posted: December 6, 2013
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Stanford University
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base
Results First Submitted: August 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
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
Interventions: Behavioral: Brief Behavioral Therapy
Behavioral: Telephone-Based Intervention
Other: Educational Intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Brief Behavioral Therapy: Undergo BBT intervention

Telephone-Based Intervention: Undergo BBT intervention

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.

Educational Intervention: Undergo HEAL

Telephone-Based Intervention: Undergo HEAL


Participant Flow:   Overall Study
    Arm I (BBT Intervention)   Arm II (Control)
STARTED   34   37 
COMPLETED   28   19 
NOT COMPLETED   6   18 
Withdrawal by Subject                6                13 
Protocol Violation                0                1 
Adverse Event                0                3 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Brief Behavioral Therapy: Undergo BBT intervention

Telephone-Based Intervention: Undergo BBT intervention

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.

Educational Intervention: Undergo HEAL

Telephone-Based Intervention: Undergo HEAL

Total Total of all reporting groups

Baseline Measures
   Arm I (BBT Intervention)   Arm II (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   37   71 
Age 
[Units: Years]
Mean (Full Range)
 50.9 
 (33 to 67) 
 53.9 
 (29 to 73) 
 52.5 
 (29 to 73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      34 100.0%      37 100.0%      71 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      34 100.0%      37 100.0%      71 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   2.7%      1   1.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   2.9%      1   2.7%      2   2.8% 
White      33  97.1%      35  94.6%      68  95.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   34   37   71 


  Outcome Measures
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1.  Primary:   Percentage of Eligible Patients Consented   [ Time Frame: baseline ]

2.  Primary:   Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT   [ Time Frame: Up to 1 month ]

3.  Primary:   Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings   [ Time Frame: Up to 1 month ]

4.  Secondary:   Change in Insomnia as Measured by the Insomnia Severity Index (ISI)   [ Time Frame: Baseline to up to 1 month ]

5.  Secondary:   Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)   [ Time Frame: Baseline to up to 1 month ]

6.  Secondary:   Change in Mean Circadian Rhythm Mesor   [ Time Frame: Baseline to up to 1 month ]

7.  Secondary:   Change in Circadian Rhythm Amplitude Over 24 Hours   [ Time Frame: baseline to up to 1 month ]

8.  Secondary:   Change in Circadian Rhythm Amplitude Over 12 Hours   [ Time Frame: baseline to up to 1 month ]

9.  Secondary:   Change in Mean Circadian Rhythm Acrophase Over 24 Hours   [ Time Frame: baseline to up to 1 month ]

10.  Secondary:   Change in Mean Circadian Rhythm Acrophase Over 12 Hours   [ Time Frame: baseline to up to 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Gary Morrow
Organization: University of Rochester
phone: 585-275-9961
e-mail: gary_morrow@urmc.rochester.edu



Responsible Party: Gary Morrow, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT02002533     History of Changes
Other Study ID Numbers: URCC12048
NCI-2013-01170 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
URCC12048 ( Other Identifier: University of Rochester )
URCC-12048 ( Other Identifier: DCP )
URCC12048 ( Other Identifier: CTEP )
UG1CA189961 ( U.S. NIH Grant/Contract )
U10CA037420 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2013
First Posted: December 6, 2013
Results First Submitted: August 30, 2017
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017