失眠作为慢性血液系统癌症患者未满足的需求：一项评估基于消费者的冥想应用程序治疗睡眠障碍的随机对照试验方案。

Insomnia as an Unmet Need in Patients With Chronic Hematological Cancer: Protocol for a Randomized Controlled Trial Evaluating a Consumer-Based Meditation App for Treatment of Sleep Disturbance.

作者信息

Huberty Jennifer, Bhuiyan Nishat, Eckert Ryan, Larkey Linda, Petrov Megan, Todd Michael, Mesa Ruben

机构信息

Science, Calm, San Francisco, CA, United States.

College of Health solutions, Arizona State University, Phoenix, AZ, United States.

出版信息

JMIR Res Protoc. 2022 Jul 1;11(7):e39007. doi: 10.2196/39007.

DOI:10.2196/39007

PMID:35776489

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9288097/

Abstract

BACKGROUND

To address the need for long-term, accessible, nonpharmacologic interventions targeting sleep in patients with chronic hematological cancer, we propose the first randomized controlled trial to determine the effects of a consumer-based mobile meditation app, Calm, on sleep disturbance in this population.

OBJECTIVE

This study aims to test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group in improving the primary outcome of self-reported sleep disturbance, as well as secondary sleep outcomes, including sleep impairment and sleep efficiency; test the efficacy of daily meditation delivered via Calm compared with a health education podcast control group on inflammatory markers, fatigue, and emotional distress; and explore free-living use during a 12-week follow-up period and the sustained effects of Calm in patients with chronic hematological cancer.

METHODS

In a double-blinded randomized controlled trial, we will recruit 276 patients with chronic hematological cancer to an 8-week app-based wellness intervention-the active, daily, app-based meditation intervention or the health education podcast app control group, followed by a 12-week follow-up period. Participants will be asked to use their assigned app for at least 10 minutes per day during the 8-week intervention period; complete web-based surveys assessing self-reported sleep disturbance, fatigue, and emotional distress at baseline, 8 weeks, and 20 weeks; complete sleep diaries and wear an actigraphy device during the 8-week intervention period and at 20 weeks; and complete blood draws to assess inflammatory markers (tumor necrosis factor-α, interleukin-6, interleukin-8, and C-reactive protein) at baseline, 8 weeks, and 20 weeks.

RESULTS

This project was funded by the National Institutes of Health National Cancer Institute (R01CA262041). The projects began in April 2022, and study recruitment is scheduled to begin in October 2022, with a total project duration of 5 years. We anticipate that we will be able to achieve our enrollment goal of 276 patients with chronic hematological cancers within the allotted project time frame.

CONCLUSIONS

This research will contribute to broader public health efforts by providing researchers and clinicians with an evidence-based commercial product to improve sleep in the long term in an underserved and understudied cancer population with a high incidence of sleep disturbance.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05294991; https://clinicaltrials.gov/ct2/show/NCT05294991.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/39007.

摘要

背景

为满足慢性血液系统癌症患者对针对睡眠的长期、可及的非药物干预措施的需求，我们开展了第一项随机对照试验，以确定一款面向消费者的移动冥想应用程序Calm对该人群睡眠障碍的影响。

目的

本研究旨在测试通过Calm进行的每日冥想与健康教育播客对照组相比，在改善自我报告的睡眠障碍这一主要结局以及包括睡眠损害和睡眠效率在内的次要睡眠结局方面的疗效；测试通过Calm进行的每日冥想与健康教育播客对照组相比，在炎症标志物、疲劳和情绪困扰方面的疗效；并探索在12周的随访期内的自由生活使用情况以及Calm对慢性血液系统癌症患者的持续影响。

方法

在一项双盲随机对照试验中，我们将招募276例慢性血液系统癌症患者参加为期8周的基于应用程序的健康干预——积极的、每日的、基于应用程序的冥想干预或健康教育播客应用程序对照组，随后进行12周的随访期。参与者将被要求在8周的干预期内每天使用指定的应用程序至少10分钟；在基线、8周和20周时完成基于网络的调查，评估自我报告的睡眠障碍、疲劳和情绪困扰；在8周的干预期内和20周时完成睡眠日记并佩戴活动记录仪；在基线、8周和20周时进行血液抽取以评估炎症标志物（肿瘤坏死因子-α、白细胞介素-6、白细胞介素-8和C反应蛋白）。