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: 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
• 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

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.

Hematologic cancers, a group of cancer sub-types that include blood- and lymph-related disorders (i.e., leukemia, lymphoma, myeloma, myeloproliferating neoplasms (MPNs) and myelodysplastic syndromes (MDS), account for 11% of all cancer diagnostics in the US. Chronic hematologic cancer (CHC) patients (i.e., chronic白血病，低年级淋巴瘤，骨髓瘤，骨髓增生性综合征和骨髓增生性肿瘤 [MPN]）具有扩展的疾病课程，通常与实体瘤癌症不同，面临着通常与感染，疲劳和情绪困扰（焦虑和抑郁）相关的慢性睡眠障碍，通常会持续到生存中。药物最常针对患有睡眠障碍的癌症患者处方；但是，它们通常会带来副作用和长期依赖的风险。失眠症（CBT-I）的认知行为疗法是治疗癌症患者睡眠障碍的最研究和第一道治疗，但是CBT-I既耗时，资源密集，也不容易获得所有癌症患者。需要长期，可访问，非药物干预措施，以针对CHC患者的睡眠。冥想是一种安全有效的非药物方法，用于改善一系列与癌症相关的症状。但是，冥想干预措施通常是在面对面交付的，由于患者报告的障碍而限制了吸收和广泛传播。智能手机应用程序（应用程序）是一种提供冥想的新型干预方法，并解决了癌症患者参与面对面干预措施（即疲劳，疼痛，运输和调度困难）的障碍，而无需CBT-I的时间和专业知识限制和药物副作用风险。 Calm是一个受欢迎且审查的基于消费者的智能手机应用程序，提供了一个创新，可访问且可扩展的平台，通过该平台为CHC患者提供冥想。 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 disorder (primary outcome), markers of infection (TNF-a, IL-6, IL-8, and CRP) fatigue, and emotional distress (anxiety, depression) (secondary outcomes) in CHC patients.评估将在干预后（距基线八周）和随访（基线20周）进行评估。参与者（n = 276）将被随机分为干预措施（10分钟/天平静的冥想）（n = 138）或对照（10分钟/天健康教育播客）组（n = 138）。我们将远程收集血液样本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作为睡眠的干预的知识和严格差距，并提供有关CHC患者持续影响以减少睡眠障碍的新数据。