Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial.
Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA): Protocol for an Efficacy Trial.
复制标题
DOI：
10.2196/52315
复制
发表时间：
2023-11-29
影响因子：
1.7
通讯作者：
中科院分区：
文献类型：
--
作者：
年轻成年癌症幸存者（YACS）患慢性失眠的风险较高，甚至在完成治疗数年后。除了潜在的健康后果外，失眠还会中断社交、教育和职业发展，就像他们试图“弥补”因癌症而失去的时间一样。失眠认知行为疗法（CBTI）被推荐为失眠的一线治疗方法，但由于一些障碍（即缺乏训练有素的提供者，地理限制，财政限制），YACS在很大程度上仍无法获得。传统的CBTI尚未适应YACS独特的发育和昼夜节律挑战。为了提高这一人群有效的行为性失眠治疗的可获得性，我们开发了青年癌症幸存者睡眠治疗教育计划（STEP-YA），这是一种低强度的教育干预，通过虚拟在线提供。在这项二期“概念验证”试验中，主要目的是测试STEP-YA改善YACS患者失眠症状和情绪的功效，并评估个性化指导提高治疗效果的效用。第二个目的是探索与STEP-YA临床显著反应相关的参与者变量。这项双组随机前瞻性试验将招募74名年龄在20岁至39岁之间、临床显著失眠的未治疗期YACS患者。每个参与者在1对1的同步在线会话中完成STEP-YA干预，由训练有素的干预师按照结构化的大纲指导。这个90分钟的干预节目提供了癌症后失眠发展的教育信息，并提供了改善失眠症状的具体建议。在会议期间，参与者回顾这些建议，并制定个性化的睡眠行动计划来实施这些建议。课程结束后，参与者被随机分为两组，一组接受两次电话辅导，另一组没有辅导，没有后续辅导。在基线和干预后4周和8周评估失眠症严重程度指数（ISI）和情绪状态简表（POMS-SF）。注册于2022年11月开始，目前有28名参与者注册。我们预计招聘将于2024年完成。主要终点是ISI评分从基线到干预后8周的变化。次要终点是干预后从基线到8周的情绪症状变化（POMS-SF）。更改分数将被视为连续变量。初步分析将使用方差分析方法。受试者内部分析将检查STEP-YA干预是否与失眠和情绪随时间的显著变化有关。2-way ANOVA将用于评估教练课程对改善治疗效果的效用。慢性失眠对青少年的医疗、教育和心理功能有显著的负面影响。STEP-YA旨在满足他们的需求；研究结果将决定干预是否保证未来的有效性和推广研究，以及是否需要个性化指导以获得充分的治疗反应。ClinicalTrials.gov NCT05358951: https://clinicaltrials.gov/study/NCT05358951 DERR1-10.2196/52315
Young adult cancer survivors (YACS) are at elevated risk for chronic insomnia, even years after completing treatment. In addition to potential health consequences, insomnia can interrupt social, educational, and vocational development just as they are trying to “make up” for time lost to cancer. Cognitive behavioral therapy for insomnia (CBTI) is recommended as first-line treatment for insomnia but remains largely unavailable to YACS due to several barriers (ie, shortage of trained providers, geographic limitations, financial limitations). Traditional CBTI has not been adapted to meet YACS’ unique developmental and circadian challenges. To improve availability of effective behavioral insomnia treatment for this population, we developed the Sleep Treatment Education Program for Young Adult Cancer Survivors (STEP-YA), a low-intensity educational intervention delivered virtually online. In this phase 2 “proof of concept” trial, primary aims are to test the efficacy of STEP-YA to improve insomnia symptoms and mood in YACS and assess the utility of individualized coaching to improve treatment effects. A secondary aim will explore participant variables associated with clinically significant response to STEP-YA. This 2-arm randomized prospective trial will enroll 74 off-treatment YACS aged 20 years to 39 years with clinically significant insomnia. Each participant completes the STEP-YA intervention in a 1-on-1 synchronous online session led by a trained interventionist following a structured outline. The 90-minute intervention presents educational information on the development of insomnia after cancer and offers specific suggestions for improving insomnia symptoms. During the session, participants review the suggestions and develop a personalized sleep action plan for implementing them. After the session, participants are randomized to either the coaching condition, in which they receive 2 telephone coaching sessions, or the no-coaching condition, which offers no subsequent coaching. The Insomnia Severity Index (ISI) and the Profile of Mood States: Short Form (POMS-SF) are assessed at baseline and 4 and 8 weeks postintervention. Enrollment began in November 2022, with 28 participants currently enrolled. We anticipate recruitment will be completed in 2024. The primary endpoint is a change in ISI score from baseline to 8 weeks postintervention. The secondary endpoint is change in mood symptoms (POMS-SF) from baseline to 8 weeks postintervention. Change scores will be treated as continuous variables. Primary analyses will use ANOVA methods. A within-subjects analysis will examine if the STEP-YA intervention is associated with significant changes in insomnia and mood over time. A 2-way ANOVA will be used to evaluate the utility of coaching sessions to improve treatment effects. Chronic insomnia has significant negative effects on YACS’ medical, educational, and psychological functioning. STEP-YA aims to address their needs; study results will determine if the intervention warrants future effectiveness and dissemination studies and if individualized coaching is necessary for adequate treatment response. ClinicalTrials.gov NCT05358951: https://clinicaltrials.gov/study/NCT05358951 DERR1-10.2196/52315