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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04317742
Other study ID # SLEEPWELL
Secondary ID 1R01CA239689
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2020
Est. completion date June 30, 2024

Study information

Verified date November 2023
Source St. Jude Children's Research Hospital
Contact Tara Brinkman, PhD
Phone 866-278-5833
Email referralinfo@stjude.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 352
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 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 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 - 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)

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (2)

Lead Sponsor Collaborator
St. Jude Children's Research Hospital National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Insomnia Severity Index (ISI) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline) This is a 7-item, Likert scale, self-report questionnaire assessing perception of sleep and consequences of insomnia. The scores range from 0 to 28 with higher values indicating increasing symptom burden. Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
Secondary Change in Childhood Cancer Survivor Study-Neurocognitive questionnaire (CCSS-NCQ) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline) The CCSS-NCQ was developed specifically to address neurocognitive concerns of adult survivors of childhood cancer and includes assessment of problems with memory, task efficiency, organization, and emotional regulation. T-scores are calculated using sibling normative data (Mean= 50, SD=10) with higher scores indicating worse problems. Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
Secondary Change in The NIH Toolbox Cognitive Battery (NIHTB-CB) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline) This is a computerized assessment that measures 3 domains of cognitive function; Executive Function, Processing Speed and Working Memory. Age, sex, and race specific T-Scores (M=50, SD=10) are calculated. Higher scores indicate better functioning. Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
Secondary Change in daily sleep behaviors evaluated by a Sleep Diary from Baseline to Post-Intervention (approximately 10 weeks after Baseline) An online diary and will be included in the SHUTi program (including the patient education arm). The sleep dairy will assess daily sleep behaviors (e.g. time in bed, sleep onset latency, nighttime awakenings, sleep quality). Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
Secondary Change in Patient Health Questionnaire (PHQ-9) scores from Baseline to Post-Intervention (approximately 6 months after Baseline) This questionnaire measures symptoms of depression. Scores range from 0 to 27 with higher scores indicating more severe symptoms. Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)]
Secondary Change in Generalized Anxiety Disorder-7 (GAD-7) scores from Baseline to Post-Intervention (approximately 6 months after Baseline) This questionnaire measures symptoms of anxiety with scores ranging from 0 to 21. Higher scores indicate greater symptoms of anxiety. Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)]
Secondary Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire (HRQoL) scores from Baseline to Post-Intervention (approximately 6 months after Baseline) This questionnaire measures general health-related quality of life. T-scores are calculated (M=50, SD=10) with higher scores indicated better quality of life. Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)]
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