Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Symptoms and General Pathology

Breast Neoplasms

Sleep Initiation and Maintenance Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Brief Behavioral Therapy for Insomnia (BBT-I)

Healthy Eating Education Learning (HEAL)

Oxana Palesh, PhD

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

Brief Behavioral Intervention for Insomnia During Chemotherapy

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.

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.

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.

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.

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.

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.

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.

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.

National Cancer Institute (NCI)

Stanford University

Oxana Palesh PhD, MPH

Control group. Healthy Eating Education Learning (HEAL)

Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Oxana Palesh, Associate Professor of Psychiatry and Behavioral Sciences

T1 (Baseline)

T2 (Post intervention)

T3 (6 months follow-up)

T4 (12 months follow-up)

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).

Insomnia Severity Index (ISI)

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).

Brief Fatigue Inventory (BFI)

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).

Clinical Assessment of Depression (CAD)

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).

Comprehensive Trail Making Test (CTMT)

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).

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

Experimental group. Brief Behavioral Therapy for Insomnia (BBT-I).

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).

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

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).

Controlled Oral Word Association Test (COWAT)

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.

Mobile Cognitive Assessment Battery (MCAB)

Experimental Group. Brief Behavioral Therapy for Insomnia (BBT-I)

Spots Global Cancer Trial Database for Brief Behavioral Intervention for Insomnia During Chemotherapy

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