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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA239689 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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 assessment of cardiovascular biomarkers (dried blood spot cards) and neurocognitive function (CNS Vital Signs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Healthy Using the Internet (SHUTi) Intervention Group | Active Comparator | Participants access and complete the SHUTi program for 9 weeks. |
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| Online Patient Education (PE) Control Group | Active Comparator | Participants access and review online patient education for 9 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Healthy Using the Internet (SHUTi) Intervention Group | Device | 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. |
| 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. Changes in scores on a scale from baseline to post-intervention are reported. | Baseline and Post-Intervention (approximately 10 weeks after Baseline)] |
| 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. The domains of memory, task efficiency, and emotional regulation are used in this study. Z-scores are calculated using sibling normative data (Mean=1, SD=0) with higher scores indicating worse problems. Changes in z-scores from baseline to post-intervention are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tara Brinkman, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
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The remaining 541 participants were randomized to complete the SHUTi intervention program or to review the online patient education materials for 9 weeks. Participants were randomized using a permuted-block method with random block sizes, stratified on sex (male/female), age (<40/>40), and cranial radiation therapy (yes/no).
1554 participants were screened and enrolled between December 2020 and February 2024. Of these, 989 were ineligible, 9 withdrew and 15 were lost to follow-up prior to randomization. 541 participants were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sleep Healthy Using the Internet (SHUTi) Intervention Group | Participants access and complete the SHUTi program for 9 weeks. Sleep Healthy Using the Internet (SHUTi) Intervention Group: 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2021 |
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| Online Patient Education (PE) Control Group | Device | 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. |
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| Baseline and Post-Intervention (approximately 10 weeks after Baseline) |
| Change in CNS Vitals Signs 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 Memory. Age, sex, and race specific Standard Scores (M=100, SD=15) are calculated. Higher scores indicate better functioning. Changes in standard scores from baseline to post-intervention are reported. | Baseline and Post-Intervention (approximately 10 weeks after Baseline)] |
| Change in Patient Health Questionnaire (PHQ-8) Scores From Baseline to 6-Month Follow-Up (Approximately 6 Months After Baseline) | This questionnaire measures symptoms of depression. Scores range from 0 to 24 with higher scores indicating more severe symptoms. Changes in scores on a scale from baseline to 6-month follow-up are reported. | Baseline and 6-Month Follow up (approximately 6 months after Baseline) |
| Change in Generalized Anxiety Disorder-7 (GAD-7) Scores From Baseline to 6-Month Follow-up (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. Changes in scores on a scale from baseline to 6-month follow-up are reported. | Baseline and 6-Month Follow up (approximately 6 months after Baseline) |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire (HRQoL) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline) | This questionnaire measures general health-related quality of life in the domains of physical and mental health. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life. The PROMIS scoring tables were used for scoring. Changes in T-scores from baseline to 6-month follow-up are reported. | Baseline and 6-Month Follow up (approximately 6 months after Baseline) |
| FG001 | Online Patient Education (PE) Control Group | Participants access and review online patient education for 9 weeks. Online Patient Education (PE) Control Group: 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. |
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| COMPLETED | Participants who completed baseline and post-intervention assessment. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sleep Healthy Using the Internet (SHUTi) Intervention Group | Participants access and complete the SHUTi program for 9 weeks. Sleep Healthy Using the Internet (SHUTi) Intervention Group: 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. |
| BG001 | Online Patient Education (PE) Control Group | Participants access and review online patient education for 9 weeks. Online Patient Education (PE) Control Group: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. Changes in scores on a scale from baseline to post-intervention are reported. | Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 10-week post-intervention assessments. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Post-Intervention (approximately 10 weeks after Baseline)] |
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| Secondary | 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. The domains of memory, task efficiency, and emotional regulation are used in this study. Z-scores are calculated using sibling normative data (Mean=1, SD=0) with higher scores indicating worse problems. Changes in z-scores from baseline to post-intervention are reported. | Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 10-week post-intervention assessments. | Posted | Mean | Standard Deviation | Z-score | Baseline and Post-Intervention (approximately 10 weeks after Baseline) |
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| Secondary | Change in CNS Vitals Signs 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 Memory. Age, sex, and race specific Standard Scores (M=100, SD=15) are calculated. Higher scores indicate better functioning. Changes in standard scores from baseline to post-intervention are reported. | Analysis based on intent to treat. Include participants who randomized and completed both the baseline and 10-week post-intervention assessments. Participants with missing or invalid CNS Vital Signs assessment in each domain (Executive function, n = 54; Memory, n = 48; Processing Speed, n=36) were removed. | Posted | Mean | Standard Deviation | Standard score | Baseline and Post-Intervention (approximately 10 weeks after Baseline)] |
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| Secondary | Change in Patient Health Questionnaire (PHQ-8) Scores From Baseline to 6-Month Follow-Up (Approximately 6 Months After Baseline) | This questionnaire measures symptoms of depression. Scores range from 0 to 24 with higher scores indicating more severe symptoms. Changes in scores on a scale from baseline to 6-month follow-up are reported. | Analysis based on intent to treat. Include participants who randomized and completed both the baseline and 6-month follow-up assessments. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6-Month Follow up (approximately 6 months after Baseline) |
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| Secondary | Change in Generalized Anxiety Disorder-7 (GAD-7) Scores From Baseline to 6-Month Follow-up (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. Changes in scores on a scale from baseline to 6-month follow-up are reported. | Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 6-month follow-up assessment. | Posted | Mean | Standard Deviation | Score on a scale | Baseline and 6-Month Follow up (approximately 6 months after Baseline) |
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| Secondary | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire (HRQoL) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline) | This questionnaire measures general health-related quality of life in the domains of physical and mental health. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life. The PROMIS scoring tables were used for scoring. Changes in T-scores from baseline to 6-month follow-up are reported. | Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 6-month follow-up assessment. | Posted | Mean | Standard Deviation | T-score | Baseline and 6-Month Follow up (approximately 6 months after Baseline) |
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Adverse event data were collected for the overall study duration, from enrollment to 6-month follow-up, for each participant.
Adverse events were self-reported by participants at any point during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sleep Healthy Using the Internet (SHUTi) Intervention Group | Participants access and complete the SHUTi program for 9 weeks. Sleep Healthy Using the Internet (SHUTi) Intervention Group: 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. | 0 | 273 | 0 | 273 | 0 | 273 |
| EG001 | Online Patient Education (PE) Control Group | Participants access and review online patient education for 9 weeks. Online Patient Education (PE) Control Group: 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. | 0 | 268 | 0 | 268 | 0 | 268 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tara Brinkman, PhD | St. Jude Children's Research Hospital | 901-595-5683 | Tara.Brinkman@STJUDE.ORG |
| Dec 11, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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| Black, non-Hispanic |
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| Hispanic |
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| Other races, non-Hispanic |
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| Unknown |
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Participants access and review online patient education for 9 weeks.
Online Patient Education (PE) Control Group: 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.
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