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.

项目概要 概述：超过 60% 的髓系肿瘤 (MN) 是在 60 岁以上的成年人中诊断出来的，并且高达 98% 这些患者[包括那些接受低甲基化药物（HMA）的患者]出现身体功能下降 和症状（例如疲劳、情绪紊乱），导致生活质量 (QoL) 下降。运动可以预防 老年 MN 患者身体机能下降并改善症状。老年 MN 患者可以 安全地锻炼，但坚持可能是一个挑战。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 失调[特别是肿瘤坏死因子 (TNF)α 和相关细胞因子]与身体状况有关 功能衰退、疲劳、情绪紊乱。在本 K99/R00 中，我们建议开发、调整和评估 一种新颖的移动健康运动干预措施，用于预防身体功能下降、改善症状，以及 预防接受门诊 HMA 的老年 MN 患者的生活质量恶化，并探讨 干预TNFα及相关细胞因子基因启动子甲基化及其基因和蛋白表达。 职业发展计划：Loh博士是一位新兴的老年肿瘤学家，并已开始研究移动医疗和 癌症控制。成为一名独立的临床科学家进行移动健康行为干预 针对老年 MN 患者的研究，Loh 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措施，(2) 获得成为独立研究者的技能 设计、进行和分析临床试验，(3) 发展身体机能生物标志物方面的专业知识。罗博士的 指导团队拥有老年病学和运动肿瘤学、行为干预研究、移动健康、 和转化科学。罗切斯特大学在老年肿瘤学和癌症控制方面是世界一流的。 研究计划：拟议的 mHealth 运动干预（GO-EXCAP 移动应用程序）整合了内容 已建立的锻炼计划 (EXCAP) 与移动应用交付平台 (TouchStream) 的结合。 EXCAP 是一个 家庭渐进式步行和阻力锻炼计划。 TouchStream 移动应用程序跟踪 运动数据、症状和运动坚持障碍，运动生理学家可以进行调整 运动处方并解决运动障碍。在K99中，我们将首先开发并适配GO-EXCAP 移动应用程序获取 10 名接受 HMA 的 MN 患者的反馈。其次，我们将进行单 Arm 1 期试验在 25 名患者中优化 GO-EXCAP 移动应用程序。在 R00（第 2 阶段随机对照 试验），我们将评估 GO-EXCAP 移动应用程序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）进行控制（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：培训和研究相结合的计划将使 Loh 博士成为为数不多的老年医学专家之一 肿瘤学研究人员正在研究移动医疗干预措施，并让她过渡到独立。