eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

Study Overview
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Brief Summary
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There is evidence that survivors of childhood cancer have a high prevalence of poor sleep, including symptoms of insomnia. Insomnia is highly comorbid and has been associated with impaired cognitive performance, a range of psychiatric disorders, cardiovascular disease, and reduced quality of life. However, we still lack knowledge about the direct impact of available internet-based insomnia treatment programs for survivors of childhood cancer experiencing insomnia, in addition to how improving insomnia symptoms impacts neurocognitive function and late health morbidities in this population. Therefore, in this study, we will utilize the resources available in the Childhood Cancer Survivor Study (CCSS) to use an accepted, established, efficacious internet-delivered CBTi insomnia treatment program and evaluate the efficacy of this program in adult survivors of childhood cancer. Positive results from this study and our use of an internet-based intervention are likely generalizable and be scalable to the large and geographically diverse population of childhood cancer survivors with chronic health conditions. Primary Objective To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer. Secondary Objectives To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer. To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment. To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.

Detailed Description
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Participants with clinically significant insomnia and neurocognitive impairment are eligible for the current study. Participants will complete a 9-week internet-based insomnia treatment program (SHUTi) or receive sleep education, depending on randomized group assignment. Participants will complete home-based assessments at 3 time points (baseline, post-intervention, 6 months). These assessments will include online questionnaires measuring insomnia symptoms, neurocognitive problems, fatigue, daytime sleepiness, and health related quality of life. In addition, at each time point participants will be asked to wear an activity monitor for one week to measure physical activity and sleep patterns. Each assessment time point will also include a home visit from Examination Management Services Inc (EMSI) to measure blood pressure, heart rate, cardiovascular biomarkers, and neurocognitive function.

Official Title
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eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial

Conditions
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Childhood Cancer, Insomnia, Neurocognitive Impairment, Survivorship, Late Effect, Sleep

Intervention / Treatment
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* Device: Sleep Healthy Using the Internet (SHUTi) Intervention Group
* Device: Online Patient Education (PE) Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrollment in CCSS Between the ages of 18 and 65 years old Clinically significant insomnia (i.e. score >15 on the Insomnia Severity Index) Neurocognitive impairment (i.e. score >84th %ile of sibling normative data in at least one domain on the CCSS-NCQ) Regular access to the internet (at least 2-3 days per week) Ability to read and speak English Exclusion Criteria: History of a brain tumor An irregular schedule that would prevent adoption of intervention strategies (i.e. work schedule resulting in usual bedtime earlier than 8 PM or later than 2 AM or arising time earlier than 4 AM or later than 10 AM) Currently pregnant or breast feeding Behavioral treatment for insomnia in the past 12 months Diagnosis of a schizophrenia or psychotic disorder Alcohol or drug abuse in past year Other concurrent sleep disorders, including narcolepsy, obstructive/central sleep apnea, or restless leg syndrome Current treatment or intervention for cognitive impairment (i.e. stimulant medication, transcranial direct current stimulation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Healthy Using the Internet (SHUTi) Intervention Group<br>Participants will receive a direct link to access the SHUTi program (per randomization) from the study team. | Device: Sleep Healthy Using the Internet (SHUTi) Intervention Group<br>* SHUTi is a fully automated, interactive and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is presented in six Cores, metered out over time.<br>|
| Active Comparator: Online Patient Education (PE) Control Group<br>Participants will receive a direct link to access online patient education (per randomization) from the study team. | Device: Online Patient Education (PE) Control Group<br>* The online PE program provides static information about: insomnia symptoms; the impact, prevalence, and causes of insomnia; when to see a doctor; and basic lifestyle, environmental, and behavioral strategies to improve sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia Severity Index (ISI) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline) | This is a 7-item, Likert scale, self-report questionnaire assessing perception of sleep and consequences of insomnia. The scores range from 0 to 28 with higher values indicating increasing symptom burden. | Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Childhood Cancer Survivor Study-Neurocognitive questionnaire (CCSS-NCQ) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline) | The CCSS-NCQ was developed specifically to address neurocognitive concerns of adult survivors of childhood cancer and includes assessment of problems with memory, task efficiency, organization, and emotional regulation. T-scores are calculated using sibling normative data (Mean= 50, SD=10) with higher scores indicating worse problems. | Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)] | 
| Change in The NIH Toolbox Cognitive Battery (NIHTB-CB) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline) | This is a computerized assessment that measures 3 domains of cognitive function; Executive Function, Processing Speed and Working Memory. Age, sex, and race specific T-Scores (M=50, SD=10) are calculated. Higher scores indicate better functioning. | Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)] | 
| Change in daily sleep behaviors evaluated by a Sleep Diary from Baseline to Post-Intervention (approximately 10 weeks after Baseline) | An online diary and will be included in the SHUTi program (including the patient education arm). The sleep dairy will assess daily sleep behaviors (e.g. time in bed, sleep onset latency, nighttime awakenings, sleep quality). | Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)] | 
| Change in Patient Health Questionnaire (PHQ-9) scores from Baseline to Post-Intervention (approximately 6 months after Baseline) | This questionnaire measures symptoms of depression. Scores range from 0 to 27 with higher scores indicating more severe symptoms. | Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)] | 
| Change in Generalized Anxiety Disorder-7 (GAD-7) scores from Baseline to Post-Intervention (approximately 6 months after Baseline) | This questionnaire measures symptoms of anxiety with scores ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety. | Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)] | 
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire (HRQoL) scores from Baseline to Post-Intervention (approximately 6 months after Baseline) | This questionnaire measures general health-related quality of life. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life. | Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)] |