eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

Last updated: November 4, 2024
Sponsor: St. Jude Children's Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Insomnia

Neuroblastoma

Cancer (Pediatric)

Treatment

Sleep Healthy Using the Internet (SHUTi) Intervention Group

Online Patient Education (PE) Control Group

Clinical Study ID

NCT04317742
SLEEPWELL
1R01CA239689
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 atleast 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

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 orarising 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 sleepapnea, or restless leg syndrome

  • Current treatment or intervention for cognitive impairment (i.e. stimulantmedication, transcranial direct current stimulation)

Study Design

Total Participants: 352
Treatment Group(s): 2
Primary Treatment: Sleep Healthy Using the Internet (SHUTi) Intervention Group
Phase:
Study Start date:
December 15, 2020
Estimated Completion Date:
January 31, 2025

Study 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 a home visit from Examination Management Services Inc (EMSI) to measure blood pressure, heart rate, cardiovascular biomarkers, and neurocognitive function.

Connect with a study center

  • St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.