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，包括血液和淋巴相关疾病（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%。慢性血液癌（CHC）患者（即，慢性 白血病、低度淋巴瘤、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，往往不同于实体瘤癌症，面临慢性睡眠 通常与炎症、疲劳和情绪困扰（焦虑和抑郁）相关的紊乱， 往往坚持到生存。药物是最常见的处方癌症患者的睡眠 然而，它们往往伴随着副作用和长期依赖的风险。认知行为 失眠疗法（CBT-I）是研究最多的治疗癌症睡眠障碍的第一线疗法 患者，但CBT-I是耗时的，资源密集型的，并不容易为所有癌症患者。那里 需要针对CHC患者的睡眠进行长期、可获得的非药物干预。 冥想是一种安全有效的非药物方法，可以改善一系列与癌症相关的疾病。 症状然而，冥想干预通常是亲自进行的，限制了吸收和 由于患者报告的障碍而广泛传播。智能手机应用程序（应用程序）是一种新颖的 提供冥想的干预方法，并解决癌症患者亲自参与的障碍 干预（即，疲劳、疼痛、交通和日程安排困难）， CBT-I的局限性和药物的副作用风险。Calm是一款广受欢迎且备受好评的消费者智能手机应用程序，它提供了一个创新、可访问和可扩展的平台， 对CHC患者进行冥想。 我们提出了一项双盲随机对照试验，以确定为期八周的“基于应用程序的健康”的有效性。 干预（即，积极的每日冥想干预[平静]或安慰剂健康教育播客对照 组[POD]）以减少睡眠障碍（主要结果），炎症标志物（TNF-α，IL-6，IL-8，和 CRP）疲劳和情绪困扰（焦虑，抑郁）（次要结局）。 评估将在基线、干预后（基线后8周）和随访（基线后20周）进行。 基线）。参与者（N=276）将随机接受干预（10分钟/天平静冥想）（n=138）或 对照组（138例），每天10 min健康教育播客。我们会远程采集血样 生物标志物测量。这项研究将填补知识和严谨的差距，提供基于智能手机的冥想作为睡眠干预，并提供关于CHC患者持续影响的新数据， 减少睡眠障碍。

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.