About this trial
Young adult cancer survivors (YACS) commonly experience chronic insomnia due to many factors such as cancer related symptoms, effects of anti-cancer therapies, co-morbid mood disorders, and/or other psychosocial and economic stressors. Cognitive behavioral therapy for insomnia (CBT-I) is the gold standard for insomnia management but remains challenging to deliver to patients due to limited numbers of trained therapists, inconvenient scheduling availability, or prohibitive therapy costs. To address this critical gap in young adult cancer survivorship, the investigators propose to develop and test efficacy of the More Sleep Hours Electronic Education Program (More SHEEP), a novel system of smart speaker, smart lighting, and specialized Wi-Fi router that delivers AI-driven CBT-I to patients at home.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-42 at time of enrollment
history of cancer diagnosis (any type) diagnosed at/after age 15, received all treatment before age 40
at least 6 months from date of cancer diagnosis
history of chronic sleep disorder with Insomnia Severity Index >/= 8
Disqualifiers
Refusal to try the study intervention
diagnosed untreated obstructive sleep apnea syndrome, or restless leg syndrome
narcolepsy, schizophrenia, bi-polar disorder, and/or poorly controlled psychiatric diagnoses
disease-related prognosis of less than 6 months or currently enrolled in hospice care
Trial design
Parallel
Treatments tested in this trial
Cognitive behavioral therapy for insomnia
BehavioralCognitive Behavioral Therapy for Insomnia (CBT-I) is a structured, evidence-based treatment that helps people change thoughts and behaviors that interfere with sleep, using techniques like stimulus control, sleep restriction, cognitive restructuring, and relaxation training.
Sleep education and skills
BehavioralDaily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep
Treatment groups
Trial outcomes
Primary outcomes
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a validated 7-item self-reported questionnaire assessing the severity of insomnia symptoms and related daytime impairment over the past two weeks. Items are scored on a 0-4 scale, producing a total score from 0 to 28, with higher scores indicating greater insomnia severity.
Secondary outcomes
Functional Assessment of Cancer Therapy - General
The Functional Assessment of Cancer Therapy - General (FACT-G) is a validated self-reported questionnaire assessing health-related quality of life in patients with cancer. The 27-item instrument evaluates physical, social/family, emotional, and functional well-being, with higher scores indicating better quality of life.
Functional Assessment of Cancer Therapy - Cognitive Function
The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) is a validated self-reported questionnaire assessing perceived cognitive function and cognitive-related quality of life in patients with cancer. The instrument evaluates domains including perceived cognitive impairments, perceived cognitive abilities, impact on quality of life, and comments from others, with higher scores indicating better perceived cognitive function.
Satisfaction with Assigned Study Intervention (Client Satisfaction Questionnaire)
The Client Satisfaction Questionnaire (CSQ) is a 10-item validated self-reported questionnaire assessing participant satisfaction with services received. The instrument evaluates perceived quality, usefulness, and overall satisfaction with care, with higher scores indicating greater satisfaction.
Recommendation of Assigned Intervention to Family/Friends
Likert scale of participant's self-report of how likely they are to recommend the assigned intervention to family/friends (1=not at all likely, 5=very likely)
Locations
Sponsors and contacts
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Medstar Health Research Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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