若年成人がん患者および生存者における慢性的な睡眠不足に対する介入
若年成人がん患者および生存者における慢性睡眠不足に対する介入：無作為化比較試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Santiago Bedoya-Moreno
- 電話番号：202-877-6759
- メール：Santiago.BedoyaMoreno@medstar.net
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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. |
|
アクティブコンパレータ：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. |
Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Insomnia Severity Index
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Assessment of Cancer Therapy - General
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Hunter Groninger, MD、Medstar Health Research Institute
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。