Clinical trial · Interventional
Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors
Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors: Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive behavioral therapy for insomnia | Behavioral | — | UNRESOLVED |
| Sleep education and skills | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Voice-activated virtual assistant-delivered cognitive behavioral therapy for insomnia
- description
- 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.
- interventionNames
- Behavioral: Cognitive behavioral therapy for insomnia
- type
- ACTIVE_COMPARATOR
- label
- Voice-activated virtual assistant-delivered sleep management skills (not CBT-I)
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 42 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * planned travel out of the continental United States during the study period.
References
Publications (0)
Data not yet available