eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

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
• Neurocognitive Impairment
• Survivorship
• Late Effect
• Sleep

Interventions

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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Tara Brinkman, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-15

Primary Completion

2025-01-15

Completion

2025-01-15

FDA Device

Yes

Countries

• United States

Study Locations