eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

NCT04317742 | Completed Results FDA Device

• 2 other identifiers: SLEEPWELL1R01CA239689
• Study Type: interventional
• Target: 1,554
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Cancer; Insomnia; Survivorship; Late Effect; Sleep; Neurocognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Childhood Cancer Survivor Study-Neurocognitive Questionnaire (CCSS-NCQ) Scores From Baseline to Post-Intervention (Approximately 10 Weeks After Baseline)

  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)

  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)

  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)

  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)

  Baseline and 6-Month Follow up (approximately 6 months after Baseline)

Study Arms (2)

Sleep Healthy Using the Internet (SHUTi) Intervention Group

ACTIVE COMPARATOR

Participants access and complete the SHUTi program for 9 weeks.

Device: Sleep Healthy Using the Internet (SHUTi) Intervention Group

Online Patient Education (PE) Control Group

ACTIVE COMPARATOR

Participants access and review online patient education for 9 weeks.

Device: Online Patient Education (PE) Control Group

Interventions

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.

Sleep Healthy Using the Internet (SHUTi) Intervention Group

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.

Online Patient Education (PE) Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Results Point of Contact

• Title: Tara Brinkman, PhD
• Organization: St. Jude Children's Research Hospital

Tara.Brinkman@STJUDE.ORG

901-595-5683

Study Officials

• Tara Brinkman, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: March 23, 2020
• Study Start: December 15, 2020
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of article publication.
• 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.

Locations

US (1)