Consumer-based meditation app, Calm, for treatment of sleep disturbance in hematological cancer patients

血液学癌症是一组癌症亚型，包括与血液和淋巴相关的疾病(即白血病、淋巴瘤、骨髓瘤、骨髓增生性肿瘤(MPN)和骨髓增生异常综合征(MDS))，占美国所有癌症诊断的11%。慢性血液病(CHC)患者(即慢性白血病、低度恶性淋巴瘤、骨髓瘤、骨髓增生异常综合征和骨髓增生性肿瘤 [MPN])有延长的病程，通常不同于实体瘤癌症，面临着慢性睡眠障碍，通常与炎症、疲劳和情绪困扰(焦虑和抑郁)有关，这些通常会持续到生存。最常见的药物是给有睡眠障碍的癌症患者开的；然而，它们经常伴随着副作用和长期依赖的风险。失眠认知行为疗法(CBT-I)是目前研究最多的治疗癌症患者睡眠障碍的一线疗法，但CBT-I耗时、资源密集，且不易为所有癌症患者所接受。需要针对慢性丙型肝炎患者的睡眠进行长期的、可获得的、非药物干预。冥想是一种安全有效的非药物方法，可以改善一系列癌症相关症状。然而，冥想干预通常是面对面提供的，由于患者报告的障碍，限制了吸收和广泛传播。智能手机应用程序(APP)是一种新颖的干预方法，用于提供冥想，解决癌症患者参与面对面干预的障碍(即疲劳、疼痛、交通和日程安排困难)，而不受CBT-I的时间和专业知识限制以及药物副作用风险。Calm是一款广受欢迎、受到高度评价的基于消费者的智能手机应用程序，它提供了一个创新、可访问和可扩展的平台，通过该平台向CHC患者提供冥想。我们提出了一项双盲随机对照试验，以确定为期八周的基于APP的健康干预(即，积极的日常冥想干预[CAMP]或安慰剂健康教育播客对照组[POD])的有效性，以减少CHC患者的睡眠障碍(主要结果)、炎症标志物(TNF-a、IL-6、IL-8和CRP)疲劳和情绪困扰(焦虑、抑郁)(次要结果)。评估将在基线、干预后(基线后8周)和后续(基线后20周)进行。参与者(N=276)将被随机分为干预组(10分钟/天平静冥想)(n=138)和对照组(10分钟/天健康教育播客)(n=138)。我们将远程采集血液样本进行生物标志物测量。这项研究将填补关于以智能手机为基础的冥想作为睡眠干预的知识和严谨性空白，并提供有关CHC患者减少睡眠障碍的持续效果的新数据。

Hematological cancers, a group of cancer sub-types that include blood- and lymph-related disorders (i.e., leukemia, lymphoma, myeloma, myeloproliferative neoplasms (MPNs) and myelodysplastic syndromes (MDS), account for 11% of all cancer diagnoses in the US. Chronic hematological cancer (CHC) patients (i.e., chronic leukemias, low grade lymphomas, myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms [MPNs]) have extended disease courses that are often different from solid tumor cancers, facing chronic sleep disturbances often associated with inflammation, fatigue, and emotional distress (anxiety and depression), which often persist into survivorship. Medications are most commonly prescribed for cancer patients with sleep disturbance; however, they often come with side effects and risk for long-term dependence. Cognitive behavioral therapy for insomnia (CBT-I) is the most studied and first line of therapy for treating sleep disturbances in cancer patients, but CBT-I is time-consuming, resource-intensive, and not easily accessible for all cancer patients. There is a need for long-term, accessible, non-pharmacologic interventions targeting sleep in CHC patients. Meditation is a safe and effective non-pharmacologic approach for improving a range of cancer-related symptoms. However, meditation interventions have typically been delivered in-person, limiting uptake and widespread dissemination due to patient-reported barriers. Smartphone applications (apps) are a novel intervention approach for delivering meditation and address cancer patients’ barriers to participating in in-person interventions (i.e., fatigue, pain, transportation, and scheduling difficulties) without the time and expertise limitations of CBT-I and side effect risks from medication. Calm is a popular and highly reviewed consumer- based smartphone app that provides an innovative, accessible and scalable platform through which to deliver meditation to CHC patients. We propose a double-blind RCT to determine the effectiveness of an eight-week “app-based wellness” intervention (i.e., active daily meditation intervention [Calm] or the placebo health education podcast control group [POD]) to reduce sleep disturbance (primary outcome), markers of inflammation (TNF-a, IL-6, IL-8, and CRP) fatigue, and emotional distress (anxiety, depression) (secondary outcomes) in CHC patients. Assessments will occur at baseline, post-intervention (eight weeks from baseline), and follow-up (20 weeks from baseline). Participants (N=276) will be randomized to an intervention (10 min/day Calm meditation) (n=138) or control (10 min/day health education podcast) group (n=138). We will remotely collect blood samples for biomarker measurement. This study will fill a knowledge and rigor gap regarding the delivery of smartphone- based meditation as an intervention for sleep and provide new data on sustained effects in CHC patients to reduce sleep disturbance.