Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

项目总结 候选人。这份K23提案将使纳尔逊博士成为一名具有以下专业知识的独立调查员 开发和测试循证干预措施，以改善患者和治疗相关结果 有血液病的患者。Nelson博士展示了作为一名临床研究人员的潜力(20篇出版物 和50多个演讲)，并通过额外的培训和指导将有助于国家和 国际社会为减轻血液病患者的症状负担和提高生活质量所作的努力。 师徒关系。导师团队由国际公认的行为学研究人员组成 干预、癌症护理和患者报告的结果(导师：Joseph Greer博士)和移植护理 和支持性护理干预(共同导师：Areej El-Jwahri，医学博士)。一个科学咨询委员会， 补充专业知识将提供以下方面的指导：定性数据方法(Lara Traeger，博士)；临床 疲劳的评估和管理(Heather Jim，博士)；以及生物统计学(Dustin Rabideau，博士)。培训 计划一下。Nelson博士将通过协调研究和培训计划(1)实现短期目标 医学问题，(2)干预发展和定性数据方法，以及(3)随机临床试验 设计、测试和评估。除了定期的导师会议和体验式培训外， 研究计划，Nelson博士将完成高级课程和教学培训，出席并在 研讨会和国家会议，并在同行评议的期刊上发表研究结果。背景资料。造血术 干细胞移植(HCT)是一种潜在的治疗危及生命的血液疾病的方法； 然而，多达%的HCT接受者在接受HCT治疗六年后仍会经历严重的疲劳。 移植。尽管常规的医疗干预措施仍然存在，但疲劳依然存在，而且经过经验检验的干预措施 在管理移植后疲劳方面很难奏效。认知行为疗法(CBT)是一种循证医学 治疗疲劳，观察到的减少疲劳的效果大小通常是两到三倍 而不是对慢性病患者进行运动干预。尽管迫切需要，CBT用于减少疲劳 尚未在HCT环境中进行调查。研究策略。为了解决这一差距，拟议的研究 采用两阶段设计来开发和测试视频会议、认知-行为干预(Vitize- HCT)，以减少疲劳并提高持续疲惫的HCT幸存者的生活质量 马萨诸塞州总医院癌症中心。第一阶段包括(1)干预发展，其投入来自 经验性文献、心理学家和肿瘤学临床医生以及对接受HCT的开放式访谈 (n=20)和临床医生(n=5)，(2)改进干预措施并评估其可接受性的先导性研究(n=6)。 第二阶段将需要进行一项随机对照试验(n=75)，以评估可行性和初步 VITALIZE-HCT在改善患者报告的疲劳和生活质量结果方面的疗效 加强日常护理。这款K23为R01在全面试验中评估疗效奠定了基础。

PROJECT SUMMARY Candidate. This K23 proposal will position Dr. Nelson to become an independent investigator with expertise in developing and testing evidence-based interventions to improve patient and treatment-related outcomes for patients with hematologic conditions. Dr. Nelson demonstrates promise as a clinical researcher (20 publications and over 50 presentations), and with additional training and mentorship will contribute to national and international efforts to reduce symptom burden and improve quality of life for patients with blood disorders. Mentorship. The mentor team is comprised of internationally recognized investigators in behavioral interventions, cancer care, and patient-reported outcomes (mentor: Joseph Greer, PhD), and transplant care and supportive care interventions (co-mentor: Areej El-Jawahri, MD). A scientific advisory committee with complementary expertise will provide guidance on: qualitative data methods (Lara Traeger, PhD); clinical assessment and management of fatigue (Heather Jim, PhD); and biostatistics (Dustin Rabideau, PhD). Training Plan. Dr. Nelson will achieve short-term goals through a coordinated research and training plan in (1) HCT medical issues, (2) intervention development and qualitative data methods, and (3) randomized clinical trial design, testing, and assessment. In addition to regular mentorship meetings and experiential training through the research plan, Dr. Nelson will complete advanced coursework and didactic trainings, attend and present at seminars and national conferences, and publish findings in peer-reviewed journals. Background. Hematopoietic stem cell transplant (HCT) is a potentially curative treatment for patients with life-threatening blood disorders; yet, as many as 64% of HCT recipients go on to experience profoundly debilitating fatigue up to six years post- transplant. Fatigue persists despite routine medical intervention, and empirically-tested interventions have been largely ineffective at managing post-transplant fatigue. Cognitive-behavioral therapy (CBT) is an evidence-based treatment for fatigue, with observed effect sizes for fatigue reduction that are often two to three times greater than exercise interventions among chronically ill patients. Despite the pressing need, CBT for fatigue reduction has not been investigated in the HCT setting. Research Strategy. To address this gap, the proposed study employs a two-stage design to develop and test a videoconference, cognitive-behavioral intervention (Vitalize- HCT) to reduce fatigue and improve quality of life among persistently fatigued HCT survivors at the Massachusetts General Hospital Cancer Center. Stage I includes (1) intervention development with input from the empirical literature, psychologists and oncology clinicians, and open-ended interviews with HCT recipients (n=20) and clinicians (n=5), and (2) a pilot study to refine the intervention and evaluate its acceptability (n=6). Stage II will entail conducting a randomized controlled trial (n=75) to assess the feasibility and preliminary efficacy of the Vitalize-HCT for improving patient-reported fatigue and QOL outcomes compared to minimally enhanced usual care. This K23 lays the groundwork for an R01 to assess efficacy in a full-scale trial.