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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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 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

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Tara Brinkman, PhD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2020-12-15
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 352
Treatments
Active_comparator: Sleep Healthy Using the Internet (SHUTi) Intervention Group
Participants will receive a direct link to access the SHUTi program (per randomization) from the study team.
Active_comparator: Online Patient Education (PE) Control Group
Participants will receive a direct link to access online patient education (per randomization) from the study team.
Related Therapeutic Areas
Sponsors
Leads: St. Jude Children's Research Hospital
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov