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

NCT ID: NCT07318545

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-05-31

Brief Summary

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.

Detailed Description

Insomnia - defined as difficulty falling asleep, staying asleep, or nonrestorative sleep - is often accompanied by symptoms that impair daily function such as fatigue, difficulty concentrating, and mood disturbance. Affecting up to 75% of the estimated 650,000 young adult cancer survivors in the United States, insomnia has a myriad of psychological and medical sequelae that compound late in long-term effects of cancer diagnosis and treatment, including increased risk of mortality. Cognitive behavioral therapy for insomnia (CBT-I) remains the gold standard for managing chronic insomnia. Nevertheless, widespread access to trained CBT-I providers, even in accredited sleep centers, remains elusive: trained CBT-I therapists remain limited in number and traditional in-person CBT-I therapy can be time and cost prohibitive for patients. Newer attempts to develop automated web-based CBT-I are more didactic than interactive and can involve counterproductive use of smartphone screens at bedtime that can be activating and suppress the melatonin needed for sleep. To address this critical gap in young adult cancer survivorship care, the investigators propose the More Sleep Hours Electronic Education Program (More SHEEP): a CBT-I solution using a screen-free, conversational, AI-driven smart speaker, custom lighting to plan, remind and support YACS about the changes required to overcome insomnia, and a smart router to report on bedtime screen use. They propose a multi-phase project involving active patient stakeholder input and an iterative design process that will achieve the following Specific Aims: Aim 1) maximize feasibility, usability, and acceptability of the interactive CBT-I prototype; Aim 2) finalize the prototype and conduct pilot field testing of the intervention for usability; Aim 3) conduct a randomized controlled trial to determine the impact of these integrated CBT-I components on insomnia symptoms among young adult cancer survivors compared to an attention control. Successful completion of these Aims will further their long-term goal of providing novel, affordable, available, scalable, evidence-driven solutions for moderate-severe chronic insomnia among young adult cancer survivors. Furthermore, this technology can eventually be translated to other patient populations living with cancer or other serious illnesses.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for insomnia

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Sleep education and skills

Intervention Type: BEHAVIORAL

Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep

Interventions

Cognitive behavioral therapy for insomnia

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.

Intervention Type: BEHAVIORAL

Sleep education and skills

Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hunter Groninger, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Central Contacts

Santiago Bedoya-Moreno

Role: CONTACT

Santiago.BedoyaMoreno@medstar.net

202-877-6759

Other Identifiers

2R44CA254637-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009801

Identifier Type: -

Identifier Source: org_study_id