An eHealth Insomnia Intervention (SHUTi) for the Improvement of Insomnia in Adult Survivors of Childhood Cancer

Status: closed to accrual

This trial studies how well an electronic (e)Health intervention, Sleep Healthy Using the Internet (SHUTi) works in improving symptoms of insomnia in adult survivors of childhood cancer. Trouble falling or staying asleep is common among survivors of childhood cancer or other serious childhood illnesses. Insomnia is defined as having trouble falling or staying sleep, or not feeling well rested after sleeping. Trouble falling or staying asleep is typically treated with face-to-face meetings with an expert, using talk therapy to learn how become aware of false or negative thinking so one can cope in a more effective way. An online version of therapy for trouble falling or staying asleep may help improve sleep and help reduce some of the other health problems linked to trouble falling or staying asleep in survivors of childhood cancer or other serious childhood illness.

Inclusion Criteria

Enrollment in Childhood Cancer Survivor Study (CCSS)
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 percentile [%ile] of sibling normative data in at least one domain on the CCSS-Neurocognitive Questionnaire [NCQ])
Regular access to the internet (at least 2-3 days per week)
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
Ability to read and speak English

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 a schizophrenia or psychotic disorder
Alcohol or drug abuse in past year * The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol use disorders and the Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with drug abuse. Both questionnaires include 10 items and are well-validated
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)

PRIMARY OBJECTIVE:

I. To examine the efficacy of an eHealth intervention for improving symptoms of insomnia among adult survivors of childhood cancer.

SECONDARY OBJECTIVES:

I. To examine the impact of an eHealth intervention for insomnia on the clinical severity of insomnia symptoms in adult survivors of childhood cancer.

II. To determine whether treatment of insomnia symptoms will improve neurocognitive function in adult survivors of childhood cancer with both insomnia and neurocognitive impairment.

III. To explore the mediating effects of improved neurocognitive function, emotional distress, and cardiovascular health on the association between insomnia symptoms and quality of life.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients access the online SHUTi program for 9 weeks consisting of personalized information specific to patients and their sleep needs along with advice and goals to help patients sleep.

GROUP II: Patients access an online patient education program for 9 weeks consisting of information about trouble sleeping and ways to improve sleep.

After completion of study, patients are followed up at 1 week and 6 months.

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An eHealth Insomnia Intervention (SHUTi) for the Improvement of Insomnia in Adult Survivors of Childhood Cancer

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