COMPLETED

eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-15
Study Completion:2025-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04317742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Enrollment in CCSS
  2. * Between the ages of 18 and 65 years old
  3. * Meeting at least one of the following three insomnia criteria:
  4. * Clinically significant insomnia (i.e. score ≥8 on the Insomnia Severity Index)
  5. * Delayed sleep onset latency (SOL) (i.e. cannot get to sleep within 30 minutes, three or more times a week)
  6. * Excessive wake after sleep onset (WASO) (i.e. nighttime awakenings lasting a total of at least 30 minutes, three or more times per week)
  7. * Neurocognitive impairment (i.e. score \>84th %ile of sibling normative data in at least one domain on the CCSS-NCQ)
  8. * Regular access to the internet (at least 2-3 days per week)
  9. * Ability to read and speak English
  10. * Access to a desktop computer or a laptop
  11. * Access to a smart phone (android or iPhone), tablet or iPad with Bluetooth Low Energy BLE 4.2 or higher
  1. * History of a brain tumor
  2. * 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)
  3. * Currently pregnant or breast feeding
  4. * Behavioral treatment for insomnia in the past 12 months
  5. * Diagnosis of schizophrenia or a psychotic disorder
  6. * Alcohol or drug abuse in past year
  7. * Other concurrent sleep disorders, including narcolepsy, obstructive/central sleep apnea, or restless leg syndrome
  8. * Current treatment or intervention for cognitive impairment (i.e. stimulant medication, transcranial direct current stimulation)

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-15
Study Completion Date2025-01-15

Study Record Updates

Study Start Date2020-12-15
Study Completion Date2025-01-15

Terms related to this study

Additional Relevant MeSH Terms

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