Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07318545

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Baseline (Day 0) and Post Intervention (6 Weeks)

    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

  1. Functional Assessment of Cancer Therapy - General

    Time frame: Baseline (Day 0) and Post Intervention (6 Weeks)

    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.

  2. Functional Assessment of Cancer Therapy - Cognitive Function

    Time frame: Baseline (Day 0) and Post Intervention (6 Weeks)

    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.

  3. Satisfaction with Assigned Study Intervention (Client Satisfaction Questionnaire)

    Time frame: Post Intervention (6 Weeks)

    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.

  4. Recommendation of Assigned Intervention to Family/Friends

    Time frame: Post Intervention (6 Weeks)

    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)

  5. System Usability Scale

    Time frame: Post Intervention (6 Weeks)

    The System Usability Scale (SUS) is a validated self-reported questionnaire assessing perceived usability of a system or technology. The 10-item instrument yields a score from 0 to 100, with higher scores indicating greater perceived usability.

Study contacts

Contact information is provided by the study sponsor or research team.

Santiago Bedoya-Moreno

CONTACT

[email protected]

202-877-6759

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors: Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.