Reducing Persistent Fatigue Following Hematopoietic Stem Cell Transplantation

减少造血干细胞移植后的持续疲劳

• 批准号: 10283002
• 负责人: Ashley Nelson
• 金额: $ 17.58万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10283002
• 关键词: Address; Advisory Committees; Autologous Transplantation; Award; Behavior Therapy; Benign; Biometry; Cancer Center; Caring; Chronic; Chronic Myeloid Leukemia; Chronically Ill; Clinical; Clinical Management; Clinical Psychology; Clinical Trials Design; Clinical assessments; Cognitive Therapy; Complex; Data; Development; Disease; Doctor of Philosophy; Enrollment; Ensure; Evidence based intervention; Evidence based treatment; Exercise; Exposure to; Fatigue; Feedback; General Hospitals; Goals; Health; Hematological Disease; Hematology; Hematopoietic Stem Cell Transplantation; Heterogeneity; Homologous Transplantation; Immunocompromised Host; Inflammatory; International; Intervention; Intervention Studies; Interview; Journals; Life; Life Style; Literature; Malignant - descriptor; Massachusetts; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methods; Nature; Oncology; Outcome; Pathway interactions; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Peer Review; Pilot Projects; Population; Positioning Attribute; Psychologist; Psychology; Publications; Publishing; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Recovery; Relapse; Reporting; Research; Research Personnel; Research Training; Sampling; Severities; Social isolation; Stem cell transplant; Structure; Supportive care; Symptoms; Testing; Therapeutic; Therapeutic Intervention; Time; Training; Transplant Recipients; Transplantation; Tyrosine Kinase Inhibitor; United States; Videoconferencing; Work; base; cancer care; care outcomes; career; clinically significant; curative treatments; design; efficacious treatment; evidence base; exercise intervention; experience; improved; meetings; mortality; patient engagement; post-transplant; post-transplant disease; recruit; reduce symptoms; skills; symposium; symptomatic improvement; therapy development; transplant survivor; treatment as usual; treatment strategy

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.

项目摘要 候选人本K23提案将使纳尔逊博士成为一名独立研究者， 开发和测试基于证据的干预措施，以改善患者和治疗相关的结果， 血液病患者。纳尔逊博士证明了作为临床研究人员的承诺（20篇出版物 和50多场演讲），并通过额外的培训和指导， 国际社会努力减轻血液病患者的症状负担并提高其生活质量。 导师制。导师团队由国际公认的行为研究人员组成， 干预措施，癌症护理和患者报告的结果（导师：Joseph Greer博士），以及移植护理 和支持性护理干预（共同导师：Areej El-Jawahri，MD）。科学咨询委员会， 互补的专业知识将提供指导：定性数据方法（Lara Traeger，PhD）;临床 疲劳的评估和管理（石楠吉姆，博士）;和生物统计学（达斯汀拉比多，博士）。培训 计划纳尔逊博士将通过协调的研究和培训计划在（1）HCT实现短期目标 医学问题，（2）干预开发和定性数据方法，（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， 根据研究计划，纳尔逊博士将完成高级课程和教学培训，参加并出席 研讨会和国家会议，并在同行评审的期刊上发表研究结果。背景造血 干细胞移植（HCT）是一种潜在的治疗危及生命的血液疾病患者的治疗方法; 然而，多达64%的HCT接受者在接受HCT后6年内继续经历严重的衰弱性疲劳， 移植尽管进行了常规的医疗干预，疲劳仍然存在，并且已经进行了实验室测试的干预措施。 在处理移植后疲劳方面基本无效。认知行为疗法（CBT）是一种基于证据的 治疗疲劳，观察到的疲劳减少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减少疲劳 尚未在HCT环境中进行研究。研究战略。为了弥补这一差距，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（Vitalize- HCT），以减轻疲劳，改善持续疲劳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）制定干预措施， 经验文献、心理学家和肿瘤学临床医生，以及对HCT接受者的开放式访谈 （n=20）和临床医生（n=5），和（2）试点研究，以完善干预措施，并评估其可接受性（n=6）。 第二阶段将进行随机对照试验（n=75），以评估可行性和初步 Vitalize-HCT在改善患者报告的疲劳和QOL结局方面的有效性， 加强常规护理。该K23为R 01在全面试验中评估疗效奠定了基础。