Trial Outcomes & Findings for eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer (NCT NCT04317742)
NCT ID: NCT04317742
Last Updated: 2026-01-07
Results Overview
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.
COMPLETED
NA
1554 participants
Baseline and Post-Intervention (approximately 10 weeks after Baseline)]
2026-01-07
Participant Flow
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.
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
COMPLETED
|
169
|
184
|
|
Overall Study
NOT COMPLETED
|
104
|
84
|
|
Overall Study
STARTED
|
273
|
268
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
57
|
59
|
|
Overall Study
Pregnancy
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
46
|
24
|
Baseline Characteristics
eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer
Baseline characteristics by cohort
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=273 Participants
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.
|
Online Patient Education (PE) Control Group
n=268 Participants
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.
|
Total
n=541 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 Years
STANDARD_DEVIATION 8.7 • n=37 Participants
|
44.8 Years
STANDARD_DEVIATION 8.7 • n=56 Participants
|
44.7 Years
STANDARD_DEVIATION 8.7 • n=95 Participants
|
|
Sex: Female, Male
Female
|
197 Participants
n=37 Participants
|
198 Participants
n=56 Participants
|
395 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=37 Participants
|
70 Participants
n=56 Participants
|
146 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
232 Participants
n=37 Participants
|
226 Participants
n=56 Participants
|
458 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
10 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
17 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 Participants
n=37 Participants
|
18 Participants
n=56 Participants
|
37 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Other races, non-Hispanic
|
10 Participants
n=37 Participants
|
16 Participants
n=56 Participants
|
26 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
3 Participants
n=95 Participants
|
|
Region of Enrollment
United States
|
273 participants
n=37 Participants
|
268 participants
n=56 Participants
|
541 participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Baseline and Post-Intervention (approximately 10 weeks after Baseline)]Population: Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 10-week post-intervention assessments.
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.
Outcome measures
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=169 Participants
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.
|
Online Patient Education (PE) Control Group
n=184 Participants
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.
|
|---|---|---|
|
Change in Insomnia Severity Index (ISI) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
|
-6.30 Score on a scale
Standard Deviation 5.04
|
-3.91 Score on a scale
Standard Deviation 4.62
|
SECONDARY outcome
Timeframe: Baseline and Post-Intervention (approximately 10 weeks after Baseline)Population: Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 10-week post-intervention assessments.
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.
Outcome measures
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=169 Participants
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.
|
Online Patient Education (PE) Control Group
n=184 Participants
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.
|
|---|---|---|
|
Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Task efficiency
|
-0.70 Z-score
Standard Deviation 1.00
|
-0.41 Z-score
Standard Deviation 0.92
|
|
Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Memory
|
-0.65 Z-score
Standard Deviation 1.01
|
-0.36 Z-score
Standard Deviation 0.87
|
|
Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Emotional regulation
|
-0.66 Z-score
Standard Deviation 0.90
|
-0.43 Z-score
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Baseline and Post-Intervention (approximately 10 weeks after Baseline)]Population: 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.
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.
Outcome measures
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=169 Participants
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.
|
Online Patient Education (PE) Control Group
n=184 Participants
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.
|
|---|---|---|
|
Change in CNS Vitals Signs Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Executive function
|
1.9 Standard score
Standard Deviation 13.0
|
3.5 Standard score
Standard Deviation 11.8
|
|
Change in CNS Vitals Signs Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Memory
|
2.6 Standard score
Standard Deviation 15.7
|
0.1 Standard score
Standard Deviation 17.2
|
|
Change in CNS Vitals Signs Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)
Processing speed
|
3.9 Standard score
Standard Deviation 12.7
|
3.3 Standard score
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline and 6-Month Follow up (approximately 6 months after Baseline)Population: Analysis based on intent to treat. Include participants who randomized and completed both the baseline and 6-month follow-up assessments.
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.
Outcome measures
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=137 Participants
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.
|
Online Patient Education (PE) Control Group
n=168 Participants
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.
|
|---|---|---|
|
Change in Patient Health Questionnaire (PHQ-8) Scores From Baseline to 6-Month Follow-Up (Approximately 6 Months After Baseline)
|
-2.7 Score on a scale
Standard Deviation 4.1
|
-1.3 Score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline and 6-Month Follow up (approximately 6 months after Baseline)Population: Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 6-month follow-up assessment.
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.
Outcome measures
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=137 Participants
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.
|
Online Patient Education (PE) Control Group
n=168 Participants
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.
|
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores From Baseline to 6-Month Follow-up (Approximately 6 Months After Baseline)
|
-2.3 Score on a scale
Standard Deviation 4.0
|
-1.4 Score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline and 6-Month Follow up (approximately 6 months after Baseline)Population: Analysis based on intent to treat. Include participants who were randomized and completed both the baseline and 6-month follow-up assessment.
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.
Outcome measures
| Measure |
Sleep Healthy Using the Internet (SHUTi) Intervention Group
n=137 Participants
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.
|
Online Patient Education (PE) Control Group
n=168 Participants
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.
|
|---|---|---|
|
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)
Physical health
|
2.5 T-score
Standard Deviation 5.7
|
1.0 T-score
Standard Deviation 5.3
|
|
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)
Mental health
|
2.6 T-score
Standard Deviation 7.1
|
1.0 T-score
Standard Deviation 6.3
|
Adverse Events
Sleep Healthy Using the Internet (SHUTi) Intervention Group
Online Patient Education (PE) Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tara Brinkman, PhD
St. Jude Children's Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place