Trial Outcomes & Findings for Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy (NCT NCT02002533)
NCT ID: NCT02002533
Last Updated: 2019-06-05
Results Overview
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.
COMPLETED
NA
71 participants
baseline
2019-06-05
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
|
Overall Study
COMPLETED
|
28
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
18
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
13
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy
Baseline characteristics by cohort
| Measure |
Arm I (BBT Intervention)
n=34 Participants
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)
n=37 Participants
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
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
n=5 Participants
|
53.9 years
n=7 Participants
|
52.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePopulation: 92 people were approached to enroll in the study
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.
Outcome measures
| Measure |
All Participants
n=92 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
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
|
|---|---|---|
|
Percentage of Eligible Patients Consented
|
77.17 percentage of participants
Interval 67.61 to 84.55
|
—
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: Data on HEAL subjects was not collected since the main focus was BBT, therefore only rate of adherence is shown for BBT group.
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%.
Outcome measures
| Measure |
All Participants
n=34 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
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
|
|---|---|---|
|
Percentage of Consented Participants Who Complete the Study, Defined as Completion of at Least 5 BBT
|
73.5 percentage of participants
Interval 55.3 to 86.5
|
—
|
PRIMARY outcome
Timeframe: Up to 1 monthPopulation: This assessment was only performed for the BBT arm.
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.
Outcome measures
| Measure |
All Participants
n=34 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
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
|
|---|---|---|
|
Percentage of Key Components of BBT Delivered by NCI Community Oncology Research Program (NCORP) Staff, Assessed by Checklist and Auditing of Audio-recordings
|
0.8075 percentage of components delivered
Standard Error 0.08450
|
—
|
SECONDARY outcome
Timeframe: Baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Insomnia as Measured by the Insomnia Severity Index (ISI)
|
-6.259 units on a scale
Standard Deviation 5.134
|
-2.450 units on a scale
Standard Deviation 6.700
|
SECONDARY outcome
Timeframe: Baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)
|
-4.000 units on a scale
Standard Deviation 3.590
|
-2.750 units on a scale
Standard Deviation 4.089
|
SECONDARY outcome
Timeframe: Baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Mean Circadian Rhythm Mesor
|
0.008 log activity counts
Standard Deviation 0.153
|
-0.046 log activity counts
Standard Deviation 0.156
|
SECONDARY outcome
Timeframe: baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Circadian Rhythm Amplitude Over 24 Hours
|
0.061 log10 (counts/minute)
Standard Deviation 0.185
|
-0.164 log10 (counts/minute)
Standard Deviation 0.194
|
SECONDARY outcome
Timeframe: baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Circadian Rhythm Amplitude Over 12 Hours
|
0.063 log10 (counts/minute)
Standard Deviation 0.164
|
0.127 log10 (counts/minute)
Standard Deviation 0.236
|
SECONDARY outcome
Timeframe: baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Mean Circadian Rhythm Acrophase Over 24 Hours
|
0.409 hours
Standard Deviation 3.698
|
-0.912 hours
Standard Deviation 2.855
|
SECONDARY outcome
Timeframe: baseline to up to 1 monthPopulation: Based on subjects that completed study through post-intervention.
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.
Outcome measures
| Measure |
All Participants
n=28 Participants
All people that were enrolled in the study regardless of intervention assigned.
|
Arm II (Control)
n=19 Participants
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
|
|---|---|---|
|
Change in Mean Circadian Rhythm Acrophase Over 12 Hours
|
0.529 hours
Standard Deviation 2.519
|
1.516 hours
Standard Deviation 4.833
|
Adverse Events
Arm I (BBT Intervention)
Arm II (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (BBT Intervention)
n=34 participants at risk
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)
n=37 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/34
|
8.1%
3/37 • Number of events 3
|
|
Gastrointestinal disorders
mucositis stomastitis
|
0.00%
0/34
|
2.7%
1/37 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/34
|
2.7%
1/37 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/34
|
2.7%
1/37 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/34
|
2.7%
1/37 • Number of events 1
|
|
Vascular disorders
hypotension
|
0.00%
0/34
|
2.7%
1/37 • Number of events 1
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
0.00%
0/34
|
2.7%
1/37 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place