Brief Behavioral Intervention for Insomnia During Chemotherapy

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Brief Behavioral Therapy for Insomnia (BBT-I)

Healthy Eating Education Learning (HEAL)

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Eating Education Learning (HEAL)

Brief Behavioral Therapy for Insomnia (BBT-I)

Arm Description

Control group.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)

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

Brief Fatigue Inventory (BFI)

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.

Clinical Assessment of Depression (CAD)

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.

Comprehensive Trail Making Test (CTMT)

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.

Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Delayed Recall

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.

Hopkins Verbal Learning Test Revised (HVLT-R) Sub-test for Verbal Learning & Memory

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.

Controlled Oral Word Association Test (COWAT)

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.

Mobile Cognitive Assessment Battery (MCAB)

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.

Full Information

NCT ID

NCT02165839

First Posted

June 11, 2014

Last Updated

December 1, 2020

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02165839

Brief Title

Brief Behavioral Intervention for Insomnia During Chemotherapy

Official Title

Brief Behavioral Intervention for Insomnia During Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

June 19, 2019 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Insomnia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Eating Education Learning (HEAL)

Arm Type

Active Comparator

Arm Description

Control group.

Arm Title

Brief Behavioral Therapy for Insomnia (BBT-I)

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Brief Behavioral Therapy for Insomnia (BBT-I)

Intervention Type

Behavioral

Intervention Name(s)

Healthy Eating Education Learning (HEAL)

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

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

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

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