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

June 8, 2026 updated by: Medstar Health Research Institute

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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.
Behavioral: Sleep education and skills
Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0) and Post Intervention (6 Weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0) and Post Intervention (6 Weeks)
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.
Baseline (Day 0) and Post Intervention (6 Weeks)
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.
Post Intervention (6 Weeks)
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)
Post Intervention (6 Weeks)
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.
Post Intervention (6 Weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medstar Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hunter Groninger, MD, Medstar Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00009801
  • 2R44CA254637-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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