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

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorMedstar Health Research Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: Voice-activated virtual assistant-delivered cognitive behavioral therapy for insomniaExperimental treatment 1 intervention
Group B: Voice-activated virtual assistant-delivered sleep management skills (not CBT-I)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Insomnia Severity Index

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.

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

Secondary outcomes

1

Functional Assessment of Cancer Therapy - General

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.

Time frame
Baseline (Day 0) and Post Intervention (6 Weeks)
2

Functional Assessment of Cancer Therapy - Cognitive Function

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.

Time frame
Baseline (Day 0) and Post Intervention (6 Weeks)
3

Satisfaction with Assigned Study Intervention (Client Satisfaction Questionnaire)

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.

Time frame
Post Intervention (6 Weeks)
4

Recommendation of Assigned Intervention to Family/Friends

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)

Time frame
Post Intervention (6 Weeks)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medstar Health Research Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: