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

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ClinicalTrials.gov Identifier: NCT02002533
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Stanford University
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

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
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 34 37
Completed 28 19
Not Completed 6 18
Reason Not Completed
Withdrawal by Subject             6             13
Protocol Violation             0             1
Adverse Event             0             3
Lost to Follow-up             0             1
Arm/Group Title Arm I (BBT Intervention) Arm II (Control) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 34 37 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 37 participants 71 participants
50.9
(33 to 67)
53.9
(29 to 73)
52.5
(29 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 71 participants
Female
34
 100.0%
37
 100.0%
71
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 71 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 37 participants 71 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 34 participants 37 participants 71 participants
34
 100.0%
37
 100.0%
71
 100.0%
1.Primary Outcome
Title Percentage of Eligible Patients Consented
Hide Description 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.
Time Frame baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
92 people were approached to enroll in the study
Arm/Group Title All Participants
Hide Arm/Group Description:
All people that were enrolled in the study regardless of intervention assigned.
Overall Number of Participants Analyzed 92
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.17
(67.61 to 84.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection All Participants
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments [Not Specified]
Method exact binomial test
Comments The percentage is greater than or equal to 40%.
2.Primary Outcome
Title Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT
Hide Description 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%.
Time Frame Up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data on HEAL subjects was not collected since the main focus was BBT, therefore only rate of adherence is shown for BBT group.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 34 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.5
(55.3 to 86.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7350
Comments [Not Specified]
Method exact binomial test
Comments [Not Specified]
3.Primary Outcome
Title Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings
Hide Description 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.
Time Frame Up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This assessment was only performed for the BBT arm.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 34 0
Mean (Standard Error)
Unit of Measure: percentage of components delivered
0.8075  (0.08450)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8075
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.08450
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Insomnia as Measured by the Insomnia Severity Index (ISI)
Hide Description

The ISI has seven questions. The seven answers are added up to get a total score.

Total score categories:

0–7 = No clinically significant insomnia 8–14 = Subthreshold insomnia 15–21 = Clinical insomnia (moderate severity) 22–28 = Clinical insomnia (severe) 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.

Time Frame Baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.259  (5.134) -2.450  (6.700)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1808
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.21
Estimation Comments The estimated value is BBT minus HEAL.
5.Secondary Outcome
Title Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
Hide Description Each item is weighted on a 0–3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. 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.
Time Frame Baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.000  (3.590) -2.750  (4.089)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.73
Estimation Comments Estimated value is BBT minus HEAL.
6.Secondary Outcome
Title Change in Mean Circadian Rhythm Mesor
Hide Description Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The mesor is the average activity over a 24 hour period.
Time Frame Baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: log activity counts
0.008  (0.153) -0.046  (0.156)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments For baseline of 0.7.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.404
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.137
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments At baseline 1.3.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.077
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments At baseline of 1.5.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.032
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.053
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments Grouped by baseline interaction.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.24
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.221
Estimation Comments The estimated value is grouped by baseline interaction parameter.
7.Secondary Outcome
Title Change in Circadian Rhythm Amplitude Over 24 Hours
Hide Description Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The ampliitude is the peak activity level over a 24 hour period.
Time Frame baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: log10 (counts/minute)
0.061  (0.185) -0.164  (0.194)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Circadian Rhythm Amplitude Over 12 Hours
Hide Description Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The amplitude is the highest activity level over a 12 hour period.
Time Frame baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: log10 (counts/minute)
0.063  (0.164) 0.127  (0.236)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change in Mean Circadian Rhythm Acrophase Over 24 Hours
Hide Description Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The acrophase is the time where peak activity occurs over a 24 hour period. The larger the acrophase the later in the day is the peak activity.
Time Frame baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: hours
0.409  (3.698) -0.912  (2.855)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.573
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title Change in Mean Circadian Rhythm Acrophase Over 12 Hours
Hide Description Activity levels were measured using an actigraphy device worn as a watch. The data was collected by the device for a 24 hour period. A model consisting of two cosine functions, one with a period of 12 hours, and the other with a period of 24 hours is fit to log activity counts as the dependent variable, and hour (0 to 24) as the independent variable. The acrophase is the time where peak activity occurs over a 12 hour period. The larger the acrophase the later in the day is the peak activity.
Time Frame baseline to up to 1 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Based on subjects that completed study through post-intervention.
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 28 19
Mean (Standard Deviation)
Unit of Measure: hours
0.529  (2.519) 1.516  (4.833)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.502
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.558
Estimation Comments Group difference (BBT - HEAL) in mean post-pre change.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.723
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.007
Estimation Comments Group difference (BBT - HEAL) in mean post-pre change.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.750
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.326
Estimation Comments Group difference (BBT - HEAL) in mean post-pre change.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm I (BBT Intervention), Arm II (Control)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.911
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.400
Estimation Comments This is an arm by baseline interaction parameter.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (BBT Intervention) Arm II (Control)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm I (BBT Intervention) Arm II (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (BBT Intervention) Arm II (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/37 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (BBT Intervention) Arm II (Control)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      3/37 (8.11%)    
Blood and lymphatic system disorders     
Febrile neutropenia *  0/34 (0.00%)  0 3/37 (8.11%)  3
Anemia *  0/34 (0.00%)  0 1/37 (2.70%)  1
Gastrointestinal disorders     
mucositis stomastitis *  0/34 (0.00%)  0 1/37 (2.70%)  1
Metabolism and nutrition disorders     
hypophosphatemia *  0/34 (0.00%)  0 1/37 (2.70%)  1
Nervous system disorders     
Headache *  0/34 (0.00%)  0 1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders     
Sore Throat *  0/34 (0.00%)  0 1/37 (2.70%)  1
Vascular disorders     
hypotension *  0/34 (0.00%)  0 1/37 (2.70%)  1
*
Indicates events were collected by non-systematic assessment
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
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 2, 2017
Last Update Posted: December 2, 2017