Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors

Sponsor
Medstar Health Research Institute
Study ID
NCT07318545
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Cognitive behavioral therapy for insomnia — BEHAVIORAL
    Cognitive 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 — BEHAVIORAL
    Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep

Study Details

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.

Key Dates

First listed
Jan 6, 2026
Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Voice-activated virtual assistant-delivered cognitive behavioral therapy for insomnia
    More Sleep Hours Electronic Education Program (More SHEEP) is a home-based, technology-enabled intervention that delivers cognitive behavioral therapy for insomnia (CBT-I) to young adult cancer survivors. The intervention uses a screen-free, voice-activated smart speaker integrated with adaptive smart lighting and internet use monitoring to provide CBT-I components including sleep education, sleep scheduling, behavioral recommendations, and daily sleep diary collection over a 6-week period.
  • Active Comparator: Voice-activated virtual assistant-delivered sleep management skills (not CBT-I)
    The active comparator arm will include the same hardware as the More SHEEP system, a screen-free, voice-activated smart speaker integrated with adaptive smart lighting and internet use monitoring, but will not deliver CBT-I, it will only include skills education to improve sleep.

Primary Outcome Measure

Insomnia Severity Index [ Time Frame: Baseline (Day 0) and Post Intervention (6 Weeks) ]

Central Contacts

Related Studies