eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep; Childhood Cancer; Survivorship; Late Effect; Neurocognitive Impairment
• Intervention / Treatment: Device: Sleep Healthy Using the Internet (SHUTi) Intervention Group; Device: Online Patient Education (PE) Control Group

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 1554
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Enrollment in CCSS
• Between the ages of 18 and 65 years old
• Meeting at least one of the following three insomnia criteria:
• Clinically significant insomnia (i.e. score ≥8 on the Insomnia Severity Index)
• Delayed sleep onset latency (SOL) (i.e. cannot get to sleep within 30 minutes, three or more times a week)
• Excessive wake after sleep onset (WASO) (i.e. nighttime awakenings lasting a total of at least 30 minutes, three or more times per week)
• 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
• Access to a desktop computer or a laptop
• Access to a smart phone (android or iPhone), tablet or iPad with Bluetooth Low Energy BLE 4.2 or higher

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 schizophrenia or a 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sleep Healthy Using the Internet (SHUTi) Intervention Group; Participants access and complete the SHUTi program for 9 weeks.	Device: 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.
Active Comparator: Online Patient Education (PE) Control Group; Participants access and review online patient education for 9 weeks.	Device: 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.

What is the study measuring?

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. Changes in scores on a scale from baseline to post-intervention are reported.	Baseline and Post-Intervention (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. 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.	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)

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tara Brinkman, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neoplasms; Sleep Initiation and Maintenance Disorders; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: SLEEPWELL; 1R01CA239689 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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
• IPD Sharing Time Frame: Data will be made available at the time of article publication.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No