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

基本信息

批准号：
10444598
负责人：
Jennifer Lynne Huberty
金额：
$ 9.58万
依托单位：
CALM.COM, INC.
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-01 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10444598
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

项目摘要

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)），占世界所有癌症诊断的 11%美国慢性血液癌症 (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]）的病程通常与实体瘤癌症不同，面临着通常与炎症、疲劳和情绪困扰（焦虑和抑郁）相关的慢性睡眠障碍，这些症状通常持续到生存期。癌症最常开药治疗。失眠认知行为疗法 (CBT-I) 是治疗癌症患者睡眠障碍的首选疗法，但通常会带来副作用和长期依赖的风险。 CBT-I 耗时、资源密集，并且并非所有癌症患者都能轻松获得。CHC 患者需要针对睡眠的长期、可及的非药物干预措施。然而，冥想干预通常是亲自进行的，由于智能手机应用程序（应用程序）是一种新颖的冥想干预方法，因此限制了其接受和广泛传播。解决癌症患者的没有 CBT-I 的时间和专业知识限制，参与现场干预的障碍（即高度疲劳、疼痛、交通和日程安排困难）以及药物副作用风险。Calm 是一款流行且经过审查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“基于应用程序的健康”干预（即主动日常冥想干预 [Calm] 的有效性）。 ] 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-a、IL-6、IL-8 和 CRP）、疲劳和情绪困扰（焦虑、抑郁）（次要结果） CHC 患者的评估将在基线、干预后（距基线 8 周）和随访（距基线 20 周）进行。参与者 (N=276) 将被随机分配接受干预（每天 10 分钟）。平静的冥想）（n = 138）或对照组（每天 10 分钟健康教育播客）（n = 138）我们将远程收集血液样本以进行生物标志物测量这项研究将填补有关基于智能手机的冥想的知识和严格性空白。作为睡眠干预措施，并提供关于 CHC 患者持续影响减少睡眠障碍的新数据。