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: 10118259
• 负责人: Kah Poh Loh
• 金额: $ 5.4万
• 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/10118259
• 关键词: Address; Adherence; Adult; Behavior Therapy; Behavioral; Biological Markers; Cancer Control; Cancer Patient; Clinical Trials; Cytokine Gene; Data; Development Plans; Diagnosis; Education; Elderly; Exercise; Fatigue; Feedback; Gene Expression; Genes; Goals; Grant; Health Sciences; Home environment; Individual; Inflammatory; Interleukin-1 beta; Interleukin-6; Interleukin-8; Interruption; Intervention; Intervention Studies; Interview; Malignant Neoplasms; Measures; Mentors; Methylation; Mobile Health Application; Moods; Myeloproliferative disease; Oncologist; Oncology; Outpatients; Pathway interactions; Patient Outcomes Assessments; Patients; Phase; Physical Capacity; Physical Function; Physical Performance; Physical activity; Placebos; Positioning Attribute; Quality of life; Randomized Controlled Trials; Research; Research Personnel; Research Priority; Scientist; Self Efficacy; Serum; Solid Neoplasm; Symptoms; TNF gene; TNFR-Fc fusion protein; TNFRSF1A gene; Training; Translational Research; Treatment Efficacy; Universities; Walking; affective disturbance; aged; arm; associated symptom; base; behavioral health intervention; cancer therapy; career development; chemotherapy; clinical practice; cytokine; design; epigenetic regulation; 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; post intervention; prevent; promoter; protein expression; public health relevance; resistance exercise; skills; standard of care; symptomatic improvement; usability

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.

项目总结 概述：超过60%的髓系肿瘤(MN)是在60岁以上的成年人中被诊断出来的，而高达98%的≥ 这些患者[包括那些接受去甲基化药物(HMA)的患者]身体功能下降。 和症状(如疲劳、情绪障碍)，导致较差的生活质量。运动可能会阻止 老年MN患者身体功能下降，症状改善。患有MN的老年患者可以 锻炼要安全，但坚持锻炼可能是个挑战。移动健康(MHealth)应用程序(APP)可能会改进 通过提高锻炼自我效能和帮助解决锻炼障碍来坚持锻炼。炎症性 调节失调[特别是肿瘤坏死因子α和相关细胞因子]与生理 功能衰退、疲劳和情绪紊乱。在本K99/R00中，我们建议开发、适应和评估 一种新的mHealth运动干预措施，可防止身体功能下降，改善症状，并 预防老年MN患者接受门诊HMA治疗后生活质量恶化的研究 干预肿瘤坏死因子α及相关细胞因子基因启动子甲基化及其基因和蛋白表达。 职业发展规划：陆恭蕙博士是一位新兴的老年肿瘤学家，并已开始研究mHealth和 癌症控制。成为指导mHealth行为干预的独立临床科学家 针对老年MN患者的研究，陆博士需要接受培训以(1)发展和适应mHealth行为 对老年癌症患者的干预，(2)获得技能，成为一名独立的调查员，可以 设计、进行和分析临床试验，(3)开发身体机能生物标志物方面的专业知识。陆恭蕙医生的 指导团队在老年和运动肿瘤学、行为干预研究、mHealth、 和翻译科学。罗切斯特大学在老年肿瘤学和癌症控制方面是世界级的。 研究计划：建议的移动健康运动干预(GO-EXCAP Mobile App)整合了内容 与移动应用程序交付平台(TouchStream)一起制定的锻炼计划(EXCAP)。EXCAP是一种 以家庭为基础的渐进式步行和阻力练习计划。TouchStream移动应用程序跟踪 运动数据、症状和坚持运动的障碍，运动生理学家可以调整 锻炼处方，解决锻炼障碍。在K99中，我们将首先开发和改编GO-EXCAP 通过收集10名接受HMA治疗的MN患者的反馈，获得移动应用程序。第二，我们将进行单一的-- ARM阶段1试验，在25名患者中优化Go-EXCAP移动应用程序。在R00中(2期随机对照 试验)，我们将评估Go-EXCAP Mobile App与化疗教育的初步疗效 对身体功能和患者报告的结果(疲劳、情绪和生活质量)的控制(行为安慰剂) 100个病人。我们还将探讨干预对肿瘤坏死因子α及相关细胞因子途径的影响。 影响：培训和研究相结合的计划将使陆博士成为为数不多的老年人之一 肿瘤学调查人员研究mHealth干预措施，并允许她过渡到独立。