Brief Behavioral Intervention for Insomnia During Chemotherapy

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02165839
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 139
• Location: 1
• Arms: 2
• Duration (Months): 65
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

PRIMARY OBJECTIVE(S):

To evaluate the efficacy of the Brief Behavioral Therapy for Insomnia (BBT-I) in treating insomnia among breast cancer patients receiving chemotherapy.

SECONDARY OBJECTIVE(S):

• To evaluate the efficacy of the BBT-I in treating cancer-related symptoms such as cancer-related fatigue and cognitive difficulties in breast cancer patients receiving chemotherapy.

• To examine potential moderators and mediators of BBT-I intervention effects on insomnia, cognitive difficulties, and fatigue. In particular, we are interested in age, depression and anxiety and side effects (hot flashes) as potential moderators of the intervention effects as well as evaluating modifiable behavioral and physiological mechanisms as hypothesized mediators

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Insomnia	Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I); Behavioral: Healthy Eating Education Learning (HEAL)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Brief Behavioral Intervention for Insomnia During Chemotherapy
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jun 19, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy Eating Education Learning (HEAL) Control group.	Behavioral: Healthy Eating Education Learning (HEAL)
Experimental: Brief Behavioral Therapy for Insomnia (BBT-I)	Behavioral: Brief Behavioral Therapy for Insomnia (BBT-I)

Outcome Measures

Primary Outcome Measures

1. Insomnia Severity Index (ISI) [12 months]

   The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: 0 to 7 = No clinically significant insomnia 8 to14 = Sub-threshold insomnia (mild) 15 to 21 = Clinical insomnia (moderate severity) 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.

Secondary Outcome Measures

1. Brief Fatigue Inventory (BFI) [12 months]

   The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

2. Clinical Assessment of Depression (CAD) [12 months]

   Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses ("Strongly Disagree" to "Strongly Agree"), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

3. Comprehensive Trail Making Test (CTMT) [At baseline, post intervention, 6 months and 12 months]

   Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

4. Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall [At baseline, post intervention, 6 months and 12 months]

   Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

5. Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory [At baseline, post intervention, 6 months and 12 months]

   Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

6. Controlled Oral Word Association Test (COWAT) [At baseline, post intervention, 6 months and 12 months]

   Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

7. Mobile Cognitive Assessment Battery (MCAB) [At baseline, post intervention, 6 months and 12 months]

   Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA

• Female

• Diagnosis of Breast Cancer (Stage I-IIIA)

• Scheduled for planned cancer treatment (eg, chemotherapy or biologic agents), or treatment is continuing

• Has ≥ 6 weeks of cancer treatment (eg, chemotherapy or biologic agents) remaining

• ≥ 21 years of age.

• Able to understand written and spoken English.

• Sleep disturbance of 8 or greater on the ISI, and insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy (to exclude pre-existing, chronic insomnia).

• Karnofsky score ≥ 70

EXCLUSION CRITERIA

• Have an unstable self-reported medical or psychiatric illness (Axis I - current or within the last 5 years).

• Be currently pregnant or nursing

• History of substance abuse or meet criteria for current alcohol abuse or dependence

• History (self-reported) of sleep apnea or restless leg syndrome (RLS)

• 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

• Unable or unwilling to discontinue anxiolytics within 4 hours of education sessions

• Irregular heartbeat or arrhythmia (self-reported or in the medical record)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, School of Medicine	Palo Alto	California	United States	94305

Sponsors and Collaborators

• Stanford University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Oxana Palesh, PhD, Stanford University

Study Documents (Full-Text)

• Informed Consent Form - Jan 31, 2019
• Study Protocol and Statistical Analysis Plan - Dec 14, 2015

More Information

Publications

None provided.

• Responsible Party: Oxana Palesh, Oxana Palesh PhD, MPH, Stanford University
• ClinicalTrials.gov Identifier: NCT02165839
• Other Study ID Numbers: IRB-30470; BRS0042; 1R01CA181659-01A1
• First Posted: Jun 18, 2014
• Last Update Posted: Dec 3, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental Group. Brief Behavioral Therapy for Insomnia (BBT-I)
Period Title: Overall Study
STARTED	66	73
COMPLETED	66	73
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)	Total
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)	Total of all reporting groups
Overall Participants	66	73	139
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	63 95.5%	63 86.3%	126 90.6%
>=65 years	3 4.5%	10 13.7%	13 9.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.7 (10.0)	51.1 (11.5)	50.4 (10.8)
Sex: Female, Male (Count of Participants)
Female	66 100%	73 100%	139 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 21.2%	6 8.2%	20 14.4%
Not Hispanic or Latino	48 72.7%	62 84.9%	110 79.1%
Unknown or Not Reported	4 6.1%	5 6.8%	9 6.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	17 25.8%	15 20.5%	32 23%
Native Hawaiian or Other Pacific Islander	1 1.5%	1 1.4%	2 1.4%
Black or African American	2 3%	4 5.5%	6 4.3%
White	40 60.6%	49 67.1%	89 64%
More than one race	2 3%	0 0%	2 1.4%
Unknown or Not Reported	4 6.1%	4 5.5%	8 5.8%
Region of Enrollment (participants) [Number]
United States	66 100%	73 100%	139 100%

Outcome Measures

1. Primary Outcome

Title	Insomnia Severity Index (ISI)
Description	The effects of the Brief Behavioral Therapy for Insomnia (BBT-I) intervention on insomnia will be measured by the Insomnia Severity Index (ISI). The ISI survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows: 0 to 7 = No clinically significant insomnia 8 to14 = Sub-threshold insomnia (mild) 15 to 21 = Clinical insomnia (moderate severity) 22 to 28 = Clinical insomnia (severe) ISI survey will be conducted at baseline, post intervention, 6 months and 12 months. The outcome is reported as the mean ISI score at baseline; immediately post-intervention (6 weeks nominal); 6 months; and 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

T2 (Post intervention): 5 participants were lost to follow up & didn't complete any measures. T3 (6 months follow-up): 16 participants did not complete any measures & were lost to follow up (including 2 deceased). T4 (12 months follow-up): 14 participants did not complete any measures & were lost to follow up (including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
Measure Participants	66	73
T1 (Baseline)	13.73 (5.11)	14.93 (4.84)
T2 (Post intervention)	11.28 (5.43)	10.16 (4.31)
T3 (6 months follow-up)	9.53 (5.33)	8.87 (5.87)
T4 (12 months follow-up)	9.51 (5.35)	8.98 (4.93)

2. Secondary Outcome

Title	Brief Fatigue Inventory (BFI)
Description	The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with the total score being the sum of a participant's individual questions scores at a timepoint and will range from 0 to 90. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall BFI scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

T2: 5 participants were lost to follow up & did not complete any measures. T3: 16 participants did not complete any measures & were lost to follow up (including 2 deceased). T4: 14 participants did not complete any measures & were lost to follow up (including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
Measure Participants	66	73
T1 (Baseline)	4.44 (2.28)	4.02 (2.27)
T2 (Post intervention)	4.32 (2.20)	3.88 (2.20)
T3 (6 months follow-up)	3.27 (2.07)	3.00 (2.03)
T4 (12 months follow-up)	3.28 (2.18)	2.80 (2.09)

3. Secondary Outcome

Title	Clinical Assessment of Depression (CAD)
Description	Anxiety and depression will be assessed by administration of the Clinical Assessment of Depression (CAD). The CAD questionnaire is a 50-item survey, with each statement having 4 possible responses ("Strongly Disagree" to "Strongly Agree"), scored from 1 to 4, The raw scores are then converted to T-scores. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. The CAD survey was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CAD scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

T2(Post intervention): 6 participants were lost to follow & did not complete any measures. T3(6 months follow-up): 19 participants did not complete follow-up study visit & were lost to follow up (including 2 deceased). T4(12 months follow-up): 17 participants did not complete follow-up study visit & were lost to follow up (including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
Measure Participants	66	73
T1 (Baseline)	54.38 (11.86)	55.44 (10.80)
T2 (Post intervention)	53.14 (11.25)	54.32 (11.59)
T3 (6 months follow-up)	51.15 (13.13)	51.40 (10.58)
T4 (12 months follow-up)	49.74 (12.58)	50.60 (10.66)

4. Secondary Outcome

Title	Comprehensive Trail Making Test (CTMT)
Description	Neuropsychological assessments will be conducted using the Comprehensive Trail Making Test (CTMT), an assessment of simple attention and executive function, consisting of 5 dot-to-dot exercises that increase with complexity and difficulty. A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean. Overall, higher values indicate better executive functioning, attention, and processing speed. The CTMT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the overall CTMT scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	At baseline, post intervention, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

T1(Baseline): 1 participant did not complete baseline assessment. T2(Post intervention): Total 7 participants were not analyzed; 6 participants were lost to follow up and 1 participant did not complete this measure T3(6 months follow-up): 19 participants did not complete follow-up (including 2 deceased). T4(12 months follow-up): 18 participants did not complete follow-up(including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
Measure Participants	66	73
T1 (Baseline)	44.22 (7.76)	41.44 (7.98)
T2 (Post intervention)	48.68 (8.79)	45.04 (8.68)
T3 (6 months follow-up)	48.68 (8.29)	46.53 (8.33)
T4 (12 months follow-up)	49.26 (7.86)	47.92 (7.56)

5. Secondary Outcome

Title	Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall
Description	Neuropsychological assessments will be conducted using the Delayed Recall sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score. A higher T scores indicating better memory (recall).A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Delayed Recall was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	At baseline, post intervention, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

T2 (Post intervention): 6 participants were lost to follow up & did not complete any measures. T3(6 months follow-up): 18 participants did not complete follow-up study visit (including 2 deceased). T4(12 months follow-up): 17 participants did not complete follow-up study visit (including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
Measure Participants	66	73
T1 (Baseline)	49.05 (10.83)	49.42 (9.58)
T2 (Post intervention)	49.06 (10.95)	46.96 (11.05)
T3 (6 months follow-up)	50.70 (9.78)	51.68 (9.63)
T4 (12 months follow-up)	52.95 (8.30)	52.68 (8.67)

6. Secondary Outcome

Title	Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory
Description	Neuropsychological assessments will be conducted using the Verbal Learning and Memory sub-test from the overall Hopkins Verbal Learning Test Revised (HVLT-R). The result values are known as the T score.The higher T scores indicating better memory (recall). A score of 50 represents the mean. A difference of 10 from the mean in either the positive or negative direction indicates a difference of one standard deviation The HVLT-R sub-test assessment for Verbal Learning and Memory was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	At baseline, post intervention, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

T2(Post intervention): 6 participants were lost to follow up & did not complete any measures. T3 (6 months follow-up): 18 participants did not complete follow-up visit (including 2 deceased). T4 (12 months follow-up): 17 participants did not complete follow-up visit (including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I).
Measure Participants	66	73
T1 (Baseline)	48.94 (11.45)	50.23 (11.30)
T2 (Post intervention)	49.44 (12.27)	50.42 (11.32)
T3 (6 months follow-up)	53.21 (10.78)	53.85 (9.66)
T4 (12 months follow-up)	56.05 (9.60)	56.93 (9.99)

7. Secondary Outcome

Title	Controlled Oral Word Association Test (COWAT)
Description	Neuropsychological assessments will be conducted using the Controlled Oral Word Association Test (COWAT), a verbal fluency task that assesses complex cognition. The test value is the the count of words that meet pre-defined criteria within 1 minute, so the minimum is 0 and no fixed maximum exists. Adjustments are made to the raw score based on participant age and education level, resulting in a scaled score. Higher scores reflect a better outcome, meaning better cognition and verbal fluency. The COWAT assessment was conducted at baseline, post intervention, 6 months, and 12 months. The outcome is reported as the mean of the COWAT score with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	At baseline, post intervention, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

T2: 6 participants were lost to follow & did not complete any measures. T3: 18 participants did not complete the 6-month follow-up study visit & were lost to follow up (including 2 deceased). T4: 17 participants did not complete the 12-month follow-up study visit & were lost to follow up (including 3 deceased).

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I).
Measure Participants	66	73
T1 (Baseline)	41.95 (9.87)	39.51 (11.97)
T2 (Post intervention)	42.19 (11.36)	40.43 (12.36)
T3 (6 months follow-up)	45.72 (11.11)	43.53 (12.06)
T4 (12 months follow-up)	44.61 (10.22)	42.73 (11.77)

8. Secondary Outcome

Title	Mobile Cognitive Assessment Battery (MCAB)
Description	Cognitive difficulties will be assessed by administration of the Mobile Cognitive Assessment Battery (MCAB), comprised of 3 neuropsychological tests and a self-reported assessment. MCAB measures cognitive flexibility, accuracy, processing speed, working memory and multitasking. The MCAB survey was to be conducted at baseline, post intervention, 6 months, and 12 months. The outcome was to be reported as the mean of the overall MCAB scores with standard deviation at baseline, immediately post-intervention (6 weeks nominal), 6 months, and 12 months.
Time Frame	At baseline, post intervention, 6 months and 12 months

Outcome Measure Data

Analysis Population Description

No analysis. The MCAB analysis was determined to not be a validated measure, and the analysis was not conducted as the scores are not standardized and results do not have meaning at this time.

Arm/Group Title	Healthy Eating Education Learning (HEAL)	Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)	Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I).
Measure Participants	0	0

Adverse Events

Time Frame	52 months
Arm/Group Title	Healthy Eating Education Learning (HEAL)		Brief Behavioral Therapy for Insomnia (BBT-I)
Arm/Group Description	Control group. Healthy Eating Education Learning (HEAL)		Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)
All Cause Mortality
	Healthy Eating Education Learning (HEAL)		Brief Behavioral Therapy for Insomnia (BBT-I)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		3/73 (4.1%)
Serious Adverse Events
	Healthy Eating Education Learning (HEAL)		Brief Behavioral Therapy for Insomnia (BBT-I)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/66 (4.5%)		7/73 (9.6%)
Blood and lymphatic system disorders
Blood Transfusion	0/66 (0%)	0	1/73 (1.4%)	1
Febrile neutropenia	2/66 (3%)	2	1/73 (1.4%)	1
General disorders
Disease Progression	0/66 (0%)	0	3/73 (4.1%)	3
Infections and infestations
Sepsis	1/66 (1.5%)	1	0/73 (0%)	0
Shingles	0/66 (0%)	0	1/73 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Flu like symptoms	0/66 (0%)	0	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Healthy Eating Education Learning (HEAL)		Brief Behavioral Therapy for Insomnia (BBT-I)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/66 (25.8%)		19/73 (26%)
Cardiac disorders
Palpitations	1/66 (1.5%)	1	0/73 (0%)	0
Chest pain- cardiac	2/66 (3%)	2	0/73 (0%)	0
Gastrointestinal disorders
Gastrointestinal disorders- other, specify: Crohn's	1/66 (1.5%)	1	0/73 (0%)	0
General disorders
Pain	2/66 (3%)	2	0/73 (0%)	0
Fever	2/66 (3%)	2	1/73 (1.4%)	1
Localized Edema	0/66 (0%)	0	1/73 (1.4%)	1
Immune system disorders
Allergic reaction	4/66 (6.1%)	5	0/73 (0%)	0
Infections and infestations
Skin infection	1/66 (1.5%)	1	1/73 (1.4%)	1
Infection: not specified	2/66 (3%)	2	1/73 (1.4%)	1
Urinary tract infection	1/66 (1.5%)	1	0/73 (0%)	0
Breast infection	0/66 (0%)	0	2/73 (2.7%)	2
Injury, poisoning and procedural complications
Seroma	0/66 (0%)	0	1/73 (1.4%)	1
Fall	4/66 (6.1%)	4	2/73 (2.7%)	2
Infusion related reaction: GI symptoms (unspecified)	1/66 (1.5%)	1	0/73 (0%)	0
Ankle fracture	0/66 (0%)	0	1/73 (1.4%)	1
Wrist fracture	1/66 (1.5%)	1	0/73 (0%)	0
Intraoperative breast injury: Breast necrosis	1/66 (1.5%)	1	0/73 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/66 (0%)	0	2/73 (2.7%)	2
Musculoskeletal and connective tissue disorders
Pain in extremity	1/66 (1.5%)	1	1/73 (1.4%)	1
Musculoskeletal and connective tissue disorder - Other, specify:Dermatomyositis	1/66 (1.5%)	1	0/73 (0%)	0
Back pain	0/66 (0%)	0	1/73 (1.4%)	1
Bone pain	1/66 (1.5%)	1	0/73 (0%)	0
Psychiatric disorders
Depression	3/66 (4.5%)	3	6/73 (8.2%)	6
Respiratory, thoracic and mediastinal disorders
Cough	1/66 (1.5%)	1	0/73 (0%)	0
Skin and subcutaneous tissue disorders
Rash Acneiform	1/66 (1.5%)	1	0/73 (0%)	0
Nail loss	1/66 (1.5%)	1	0/73 (0%)	0
Vascular disorders
Hematoma	1/66 (1.5%)	1	1/73 (1.4%)	1
Hypotension	1/66 (1.5%)	1	0/73 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.