Clinical trial NCT04317742: eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer
Official title: eHealth Insomnia Intervention for Adult Survivors of Childhood Cancer: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Insomnia
Neurocognitive Impairment
Survivorship
Late Effect
Sleep
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-23
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Insomnia Severity Index (ISI) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
Secondary outcomes:
measure: Change in Childhood Cancer Survivor Study-Neurocognitive questionnaire (CCSS-NCQ) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
measure: Change in The NIH Toolbox Cognitive Battery (NIHTB-CB) scores from Baseline to Post-Intervention (approximately 10 weeks after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
measure: Change in daily sleep behaviors evaluated by a Sleep Diary from Baseline to Post-Intervention (approximately 10 weeks after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 10 weeks after Baseline)]
measure: Change in Patient Health Questionnaire (PHQ-9) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)]
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)]
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire (HRQoL) scores from Baseline to Post-Intervention (approximately 6 months after Baseline)
timeFrame: Baseline and Post-Intervention Follow up (approximately 6 months after Baseline)]
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Tara Brinkman, PhD
role: PRINCIPAL_INVESTIGATOR
References: