Patient-Oriented Research and Mentoring in Hematopoietic Cell Transplantation

以患者为中心的造血细胞移植研究和指导

• 批准号: 10413848
• 负责人: SUNG WON CHOI
• 金额: $ 12.33万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10413848
• 关键词: Active Learning; Acute Graft Versus Host Disease; Address; Adolescent and Young Adult; Adult; Affect; Allogenic; Applications Grants; Area; Attitude; Behavior Therapy; Biological; Biological Process; Biological Products; Blood specimen; Cardiovascular Diseases; Caregivers; Caring; Child; Childhood; Clinical; Clinical Investigator; Clinical Trials; Clinical Trials Design; Clinical Trials Support Unit; Clinical and Translational Science Awards; Collection; Communication; Complement; Correlative Study; Coupled; Data; Data Analytics; Data Collection; Data Science; Development; Development Plans; Diabetes Mellitus; Dose; Effectiveness; Electronic Health Record; Environment; Ethics; Family Caregiver; Frequencies; Functional disorder; Funding; Future; Goals; Grant; Growth; HDAC4 gene; Health; Health Technology; Healthcare; Hematological Disease; Hematology; Histone Deacetylase; Histone Deacetylase Inhibitor; Immunotherapy; Individual; Infrastructure; Institutes; Intervention; Interview; Joints; Knowledge; Lead; Life; Manuscripts; Measures; Mental Health; Mental disorders; Mentors; Michigan; Mid-Career Clinical Scientist Award (K24); Mobile Health Application; Modernization; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Neurocognitive; Outcome; Participant; Patient Self-Report; Patients; Pediatric Oncologist; Pharmacologic Substance; Phase I/II Clinical Trial; Physicians; Physiological; Population; Prevention strategy; Prophylactic treatment; Psychology; Public Health Schools; Randomized; Randomized Controlled Trials; Research; Research Methodology; Research Personnel; Research Project Grants; Resources; Safety; Savings; Science; Scientist; Solid; Technology; Testing; Time; Training; Transplant Recipients; United States National Institutes of Health; Universities; Vorinostat; Writing; acceptability and feasibility; adaptive intervention; base; behavioral study; care delivery; career; cognitive testing; design; early phase clinical trial; early phase trial; effective therapy; experience; global health; graft vs host disease; health care service utilization; health related quality of life; hematopoietic cell transplantation; high risk; human disease; human subject protection; improved; innovation; insight; interest; intervention delivery; mHealth; mortality; multidisciplinary; next generation; novel; novel therapeutics; patient oriented research; pharmacokinetics and pharmacodynamics; physical conditioning; post-transplant; prevent; prevention clinical trial; primary outcome; programs; psychosocial; randomized trial; research study; safety testing; secondary outcome; skills; smoking cessation; social; tool; training opportunity; trend; trial design; wearable sensor technology

ABSTRACT The candidate, Sung Won Choi MD MS, is a physician-scientist who has developed a career in patient-oriented research (POR). She is an active clinical pediatric oncologist who focuses on treating life-threatening blood diseases with novel immune-based therapies, such as allogeneic hematopoietic cell transplant (HCT). Despite the potentially curative intent of HCT, its broader application has been limited by acute graft-versus host disease (GVHD). Unfortunately, acute GVHD can negatively impact clinical and health-related quality of life (HRQOL) outcomes and lead to substantial morbidity and mortality. Dr. Choi’s research program has focused on designing innovative clinical trials to mitigate acute GVHD by incorporating biological, clinical, and psychosocial correlative studies and leveraging modern mobile health technologies to further enhance care delivery. Thus, her research program provides a unique training opportunity for early stage investigators interested in POR, which is complemented by the following outstanding resources at the University of Michigan: (1) NHLBI T32 Training Grant in Hematology (T32 HL007622); (2) Michigan Institute for Clinical and Health Research (MICHR) | Clinical and Translational Science Award (UL1TR002240); (3) Clinical Trials Support Unit; and (4) School of Public Health. This ideal training environment will allow young, clinical investigators to develop and gain new skills in clinical trials design, qualitative and quantitative research methods, communication and presentation skills, manuscript and grant writing, professional growth, individual development plans, team science projects, ethical conduct of research, and protection of human subjects. Indeed, this rich environment has influenced Dr. Choi’s overall career goal of designing rigorous POR studies, mentoring the next generation of POR investigators, and together with her mentees, making meaningful contributions to the clinical and HRQOL outcomes of family caregivers and HCT patients through joint productive activity. In this application, Dr. Choi proposes didactic courses and group discussions coupled with experiential training in her currently funded research projects: in a phase I/II clinical trial, to test the safety and efficacy of a histone deacetylase (HDAC) inhibitor to prevent acute GVHD in pediatric HCT (Aim 1); in a mobile health randomized trial, to examine the effectiveness of Roadmap 2.0, a positive psychology intervention in family caregivers of HCT patients (Aim 2). Dr. Choi will also develop new research directions by generating preliminary data for a future, full-scale just-in-time adaptive intervention (JITAI) to promote physical and mental HRQOL in family caregivers of HCT patients (Aim 3). This new research direction is a logical extension of Aim 2. Thus, these projects will collectively provide Dr. Choi’s trainees with unique experiences in: i) multidisciplinary team science; ii) designing, conducting, and analyzing pharmaceutical and non-pharmaceutical (social and behavioral) interventions; iii) early phase clinical trial design and randomized controlled trial design; and iii) and generating new research ideas as well as preliminary data for future grant applications. Dr. Choi will expand her mentoring activities and build core knowledge in professional development.

抽象的 候选人Sung Won Choi MD MS是一位身体科学家，他从事以患者为导向的职业 研究（POR）。她是一个活跃的临床小儿肿瘤学家，专注于治疗生命的血液 具有新型免疫疗法的疾病，例如同种异体造血细胞移植（HCT）。尽管 HCT的潜在治愈意图，其更广泛的应用受到急性移植物宿主疾病的限制 （GVHD）。不幸的是，急性GVHD会对临床和健康相关的生活质量（HRQOL）产生负面影响 结果并导致大量发病率和死亡率。崔博士的研究计划专注于设计 通过纳入生物，临床和社会心理相关性来减轻急性GVHD的创新临床试验 研究和利用现代移动健康技术进一步增强了护理服务。那，她的研究 计划为对POR感兴趣的早期调查人员提供了独特的培训机会， 由密歇根大学以下未来资源完成：（1）NHLBI T32培训 血液学授予（T32 HL007622）; （2）密歇根州临床与健康研究所（MICHR）|临床 和翻译科学奖（UL1TR002240）； （3）临床试验支持单位； （4）公立学校 健康。这种理想的培训环境将使年轻的临床研究人员能够发展并获得新的技能 临床试验设计，定性和定量研究方法，沟通和演示技巧， 手稿和赠款写作，专业成长，个人发展计划，团队科学项目，道德 进行研究和保护人类受试者。确实，这个丰富的环境影响了崔博士 设计严格的POR研究，为下一代POR调查人员和 与她的Menees一起，为家庭的临床和HRQOL结果做出有意义的贡献 护理人员和HCT患者通过共同的生产活动。在此应用程序中，崔博士提案DIDACTIC 课程和小组讨论以及当前资助的研究项目中的专家培训，在 I/II期临床试验，以测试组蛋白脱乙酰基酶（HDAC）抑制剂的安全性和效率 小儿HCT中的GVHD（AIM 1）；在移动健康随机试验中，以检查路线图的有效性 2.0，对HCT患者家庭护理人员的积极心理学干预（AIM 2）。崔博士也将发展 新的研究指示通过生成初步数据，以实现未来的全尺度即时自适应干预措施 （Jitai）在HCT患者的家庭护理人员中促进身体和心理HRQOL（AIM 3）。这项新研究 方向是AIM 2的逻辑扩展。这些项目将共同向Choi博士的受训者提供 在以下方面的独特经验：i）多学科团队科学； ii）设计，进行和分析的药物 和非药物（社会和行为）干预措施； iii）早期临床试验设计和随机分组 对照试验设计； iii）并生成新的研究思想以及未来赠款的初步数据 申请。崔博士将扩大她的心理活动，并在专业发展中建立核心知识。