Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Cognitive behavioral therapy for insomnia (Behavioral)
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.
干预措施: Sleep education and skills (Behavioral)
结局指标
主要结局
Insomnia Severity Index
时间窗: 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.
次要结局
- Functional Assessment of Cancer Therapy - General(Baseline (Day 0) and Post Intervention (6 Weeks))
- Functional Assessment of Cancer Therapy - Cognitive Function(Baseline (Day 0) and Post Intervention (6 Weeks))
- Satisfaction with Assigned Study Intervention (Client Satisfaction Questionnaire)(Post Intervention (6 Weeks))
- Recommendation of Assigned Intervention to Family/Friends(Post Intervention (6 Weeks))
- System Usability Scale(Post Intervention (6 Weeks))
