A novel mobile health exercise intervention for older patients with myeloid neoplasms

针对老年髓系肿瘤患者的新型移动健康运动干预

• 批准号: 10018836
• 负责人: Kah Poh Loh
• 金额: $ 16.56万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018836
• 关键词: Address; Adherence; Adult; Behavior Therapy; Behavioral; Biological Markers; Cancer Control; Clinical Trials; Cytokine Gene; Data; Development Plans; Diagnosis; Education; Elderly; Exercise; Fatigue; Feedback; Gene Expression; Health Sciences; Home environment; Inflammatory; Intervention; Intervention Studies; Malignant Neoplasms; Mentors; Methylation; Mobile Health Application; Moods; Myeloproliferative disease; Oncologist; Oncology; Outpatients; Pathway interactions; Patient Outcomes Assessments; Patients; Phase; Physical Function; Placebos; Positioning Attribute; Quality of life; Randomized Controlled Trials; Research; Research Personnel; Scientist; Self Efficacy; Symptoms; TNF gene; Training; Translational Research; Universities; Walking; affective disturbance; aged; arm; base; behavioral health intervention; career development; chemotherapy; cytokine; design; exercise adherence; exercise intervention; exercise physiologist; exercise prescription; exercise program; experience; factor A; improved; intervention effect; mHealth; mobile application; novel; older patient; phase I trial; prevent; promoter; protein expression; resistance exercise; skills; symptomatic improvement

PROJECT SUMMARY Overview: Over 60% of myeloid neoplasms (MN) are diagnosed in adults aged ≥60 years, and up to 98% of these patients [including those receiving hypomethylating agents (HMA)] experience physical function decline and symptoms (e.g. fatigue, mood disturbances), leading to poor quality of life (QoL). Exercise may prevent physical function decline and improve symptoms in older patients with MN. Older patients with MN can exercise safely, but adherence may be a challenge. Mobile health (mHealth) application (app) may improve adherence by enhancing exercise self-efficacy and by helping to address barriers to exercise. Inflammatory dysregulation [specifically tumor necrosis factor (TNF)α and related cytokines] is associated with physical function decline, fatigue, and mood disturbances. In this K99/R00, we propose to develop, adapt, and evaluate a novel mHealth exercise intervention for preventing physical function decline, improving symptoms, and preventing worsening QoL in older patients with MN receiving outpatient HMA, and to explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression. Career Development Plan: Dr. Loh is an emerging geriatric oncologist and has begun to study mHealth and cancer control. To become an independent clinician scientist conducting mHealth behavioral intervention research for older patients with MN, Dr. Loh needs training to (1) develop and adapt mHealth behavioral interventions for older patients with cancer, (2) acquire skills to become an independent investigator who can design, conduct, and analyze clinical trials, (3) develop expertise in biomarkers of physical function. Dr. Loh's mentoring team has expertise in geriatric and exercise oncology, behavioral intervention research, mHealth, and translational science. The University of Rochester is world-class for geriatric oncology and cancer control. Research Plan: The proposed mHealth exercise intervention (GO-EXCAP Mobile App) integrates the content of an established exercise program (EXCAP) with a mobile app delivery platform (TouchStream). EXCAP is a home-based progressive walking and resistance exercise program. The TouchStream mobile app tracks exercise data, symptoms, and barriers to exercise adherence, and the exercise physiologist can adjust exercise prescriptions and address barriers to exercise. In K99, we will first develop and adapt the GO-EXCAP Mobile App by obtaining feedback from 10 patients with MN receiving HMA. Second, we will conduct a single- arm phase 1 trial to optimize the GO-EXCAP Mobile App in 25 patients. In R00 (phase 2 randomized controlled trial), we will assess the preliminary efficacy of the GO-EXCAP Mobile App versus a chemotherapy education control (behavioral placebo) on physical function and patient-reported outcomes (fatigue, mood, and QoL) in 100 patients. We will also explore the effect of the intervention on TNFα and related cytokine pathways. Impact: The combined training and research plan will position Dr. Loh to become one of the few geriatric oncology investigators studying mHealth interventions, and to allow her to transition to independence.

项目摘要 概述：超过60％的髓样肿瘤（MN）在≥60岁的成年人中被诊断出，最多98％ 这些患者（包括接受次甲基剂（HMA）的患者）经历身体功能下降 和符号（例如疲劳，情绪障碍），导致生活质量差（QOL）。运动可能会阻止 MN患者的身体功能下降并改善了老年患者的症状。具有MN的老年患者可以 安全锻炼，但依从性可能是一个挑战。移动健康（MHealth）应用程序（APP）可能会改善 通过增强锻炼自我效能和帮助解决运动障碍来遵守。炎症 失调[特异性肿瘤坏死因子（TNF）α和相关细胞因子]与物理有关 功能下降，疲劳和情绪障碍。在此K99/R00中，我们建议开发，适应和评估 一种新型的MHealth运动干预措施，以防止身体机能下降，改善症状和 防止MN接受门诊HMA的老年患者的担心QOL，并探索 对TNFα和相关细胞因子基因启动子甲基化及其基因和蛋白质表达的干预。 职业发展计划：Loh博士是一位新兴的老年肿瘤学家，已开始研究MHealth和 癌症控制。成为一名独立的临床科学家，进行MHealth行为干预 LOH博士对老年患者的研究需要（1）发展和适应MHealth行为 对老年癌症患者的干预措施，（2）获取技能，成为一名独立研究者 设计，进行和分析临床试验，（3）在身体机能的生物标志物中发展专业知识。 Loh博士 指导团队在老年医学和运动肿瘤学，行为干预研究，MHealth中具有专业知识， 和翻译科学。罗切斯特大学（University of Rochester）是世界一流的老年肿瘤学和癌症控制。 研究计划：拟议的MHealth练习干预（GO-EXCAP移动应用程序）集成了内容 具有移动应用程序交付平台（触摸流）的既定锻炼计划（EXPAP）。拆除是一个 家庭渐进式步行和抵抗运动计划。触摸流动应用程序轨道 运动数据，症状和遵守障碍，运动生理学家可以调整 锻炼处方并解决运动的障碍。在K99中，我们将首先开发并调整GO-EXCAP 通过从10名MN接受HMA的患者的反馈中获得移动应用程序。其次，我们将进行一次 ARM 1阶段试验以优化25名患者的GO-EXCAP移动应用程序。在R00中（2阶段随机控制 试验），我们将评估GO-EXCAP移动应用程序与化学疗法教育的初步效率 在身体机能和患者报告的结果（疲劳，情绪和QoL）中控制（行为安慰剂） 100名患者。我们还将探讨干预对TNFα和相关细胞因子途径的影响。 影响：联合培训和研究计划将使Loh博士成为少数几种老年医生之一 研究MHealth干预措施的肿瘤学研究者，并使她过渡到独立性。