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

基于消费者的冥想应用程序 Calm，用于治疗血液癌症患者的睡眠障碍

• 批准号: 10684545
• 负责人: Jennifer Lynne Huberty
• 金额: $ 47.98万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2027-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684545
• 关键词: Address; Aftercare; Anxiety; Attention; Behavioral; Biological; Biological Markers; Blood; Blood specimen; Breast Cancer Patient; Cancer Patient; Cellular Phone; Chronic; Clinical; Cognitive; Cognitive Therapy; Consumption; Control Groups; Data; Dependence; Diagnosis; Disease; Distress; Dose; Double-Blind Method; Dysmyelopoietic Syndromes; Elderly; Ethnic Origin; Evidence based treatment; Fatigue; Gender; Health education; Hematologic Neoplasms; IL8 gene; Inflammation; Interleukin-6; Intervention; Knowledge; Lead; Lymph; Lymphoma; Malignant Neoplasms; Measurement; Measures; Mediation; Meditation; Mental Depression; Methods; Middle Insomnia; Multiple Myeloma; Myeloproliferative disease; Outcome; Pain; Participant; Patient Recruitments; Patient Representative; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Physical Function; Pittsburgh Sleep Quality Index; Placebos; Quality of life; Race; Randomized; Reporting; Research; Residual Neoplasm; Resources; Risk; Schedule; Self Management; Severities; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Solid Neoplasm; Survivors; Symptoms; TNF gene; Testing; Time; Transportation; Work; actigraphy; active control; base; cancer care; cancer diagnosis; cancer pharmacology; cancer subtypes; care providers; cognitive function; depressive symptoms; diaries; effectiveness evaluation; efficacy testing; emotional distress; empowered; experience; falls; follow-up; health management; improved; improved outcome; indexing; industry partner; inflammatory marker; innovation; interest; leukemia; leukemia/lymphoma; malignant breast neoplasm; mindfulness intervention; mobile application; novel; patient-level barriers; persistent symptom; podcast; post intervention; primary outcome; psychologic; secondary outcome; side effect; smartphone Application; survivorship; uptake

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.

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]）具有延长的疾病病程，通常与实体瘤癌症不同，面临慢性睡眠障碍，通常与炎症，疲劳和情绪困扰（焦虑和抑郁）相关，这些疾病通常持续到生存期。药物最常用于患有睡眠障碍的癌症患者;然而，它们通常具有副作用和长期依赖的风险。失眠的认知行为疗法（CBT-I）是治疗癌症患者睡眠障碍的研究最多的第一线疗法，但CBT-I耗时，资源密集，并且不容易为所有癌症患者所用。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，可以改善一系列癌症相关症状。然而，冥想干预通常是亲自进行的，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（应用程序）是一种新型的干预方法，用于提供冥想和解决癌症患者参与面对面干预的障碍（即，疲劳、疼痛、运输和日程安排困难），而没有CBT-I的时间和专业知识限制以及药物的副作用风险。Calm是一款广受欢迎且备受好评的基于消费者的智能手机应用程序，它提供了一个创新的、可访问的和可扩展的平台，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“基于应用程序的健康”干预的有效性（即，积极的每日冥想干预[Calm]或安慰剂健康教育播客对照组[POD]），以减少CHC患者的睡眠障碍（主要结局）、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）。将在基线、干预后（自基线起8周）和随访（自基线起20周）时进行评估。参与者（N=276）将被随机分配到干预组（10分钟/天平静冥想）（n=138）或对照组（10分钟/天健康教育播客）（n=138）。我们将远程采集血液样本用于生物标志物测量。这项研究将填补关于提供基于智能手机的冥想作为睡眠干预的知识和严谨性空白，并提供关于CHC患者减少睡眠障碍的持续效果的新数据。