eHealth Supported Mindfulness-based Music Therapy Intervention (eMBMT) in Hemopoietic Stem Cell Transplant Patients

eHealth 支持造血干细胞移植患者的正念音乐治疗干预 (eMBMT)

基本信息

批准号：
10701885
负责人：
Teresa Lynn Lesiuk
金额：
$ 42.85万
依托单位：
UNIVERSITY OF MIAMI CORAL GABLES
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-09 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10701885
关键词：
Acute Address Adherence Allogenic Anxiety Attention Behavioral Breast Cancer survivor Cancer Patient Cancer Survivor Cancer Survivorship Chronic Clinical Cognition Complex Development Diarrhea Disease Distress Elements Fatigue Focus Groups Future Glucocorticoids Health Hematologic Neoplasms Hematopoietic Stem Cell Transplantation Hematopoietic stem cells Immunocompetence Impaired health Inflammation Inflammatory Integrative Medicine Intervention Length of Stay Longterm Follow-up Malignant Neoplasms Mediating Mental Depression Methods Modality Modeling Monitor Moods Music Music Therapy Nausea Outcome Outcome Measure Outcome Study Pain Patient-Focused Outcomes Patients Persons Phase Physiological Physiological Adaptation Physiological Processes Play Population Procedures Protocols documentation Psychological Side Effects Radiation therapy Randomized Recovery Regimen Reporting Reproducibility Research Self Management Sleep Stem cell transplant Symptoms T-Lymphocyte Therapeutic Therapeutic Intervention Training Transplant Recipients Uncertainty Work attentional control chemotherapy chronic graft versus host disease cognitive function conditioning cytokine design disabling symptom eHealth emotional distress field study follow-up health related quality of life immune reconstitution improved innovation instrument intervention delivery mindfulness mindfulness meditation mortality negative mood novel patient oriented post-transplant prevent primary outcome programs psychological distress psychosocial reduce symptoms secondary outcome side effect stress management symptomatic improvement usability

项目摘要

Allogeneic hematopoietic stem cell transplantation (allo-SCT) is a potentially curative procedure for many hematologic malignancies. Due to the intensive conditioning regimen (e.g., radiotherapy, chemotherapy) and post-transplant complications, allo-SCT is associated with multiple physical and psychological side effects including symptom burden (e.g., fatigue, pain), and poor psychosocial function and emotional distress (e.g., anxiety, depression) that impair health-related quality of life (HRQoL), and occur within the context of following a strict self-management protocol to prevent treatment-related complications. Novel, integrative, engaging, low-demand and scalable programs to reduce symptom burden and improve health related quality of life (HRQoL) and health outcomes in allo-SCT are needed, yet limited work has addressed the development and implementation music therapy—a therapeutic approach that can favorably impact health outcomes in cancer survivors. Mindfulness-based music therapy (MBMT) blends core elements of mindfulness and tailored music intervention components (e.g., songwriting, instrument playing) delivered by a trained music therapist. Our transdisciplinary team has shown that (a) MBMT reduces negative mood, fatigue, and anxiety in breast cancer survivors, (b) stress management and mindfulness improve physiological adjustment (e.g., reduced inflammation) and HRQoL in various cancer survivorship populations, and (c) that eHealth platforms can facilitate effective delivery of psychosocial interventions in cancer patients and survivors. However, studies implementing the first step in developing and evaluating well-designed, feasible, acceptable, and reproducible eHealth facilitated MBMT (eMBMT) interventions to improve patient outcomes are limited. Further, how specific music therapy components impact psychosocial (e.g., anxiety, depression) and physiological (e.g., inflammation, immunocompetence) mechanisms is not well understood. Using our expertise in mix-methods approaches, eHealth, allo-SCT, and MBMT, we address these gaps and propose to establish acceptability, feasibility and intended effects of a novel eHealth facilitated eMBMT in reducing symptom burden and improving HRQoL (Primary Outcomes), improving psychosocial and physiological adaptation and (e.g., cancer distress, reduced inflammation, T-cell recovery/immune reconstitution) (eMBMT Mechanisms), and ameliorating disease activity (e.g., GVHD) (Secondary Outcomes) in patients undergoing allo-SCT. In the R61 Phase we implement a mixed-methods (e.g., focus groups, small RCT) design to finalize eMBMT and a mindfulness meditation (eMM) control condition, establish feasibility and begin to identify music therapy components that favorably impact our study outcomes/mechanisms. In our R33 Phase we conduct a larger scale pilot RCT informed by the R61 findings to establish intended effects of eMBMT music therapy components on HRQOL, symptom burden and psychosocial and physiologic adaptation. Findings will guide a large-scale RCT with long-term follow-up and additional clinical outcomes.

异基因造血干细胞移植（allo-SCT）对于许多人来说是一种潜在的治愈方法由于强化调理方案（例如放疗、化疗）和血液系统恶性肿瘤。移植后并发症，allo-SCT 与多种身体和心理副作用相关包括症状负担（例如疲劳、疼痛）以及心理社会功能不良和情绪困扰（例如焦虑、抑郁）会损害健康相关的生活质量 (HRQoL)，并且发生在这种情况下遵循严格的自我管理方案以预防与治疗相关的并发症。综合性、参与性、低需求和可扩展的计划，以减轻症状负担并改善健康相关需要allo-SCT 的生活质量 (HRQoL) 和健康结果，但解决这一问题的工作有限开发和实施音乐疗法——一种可以对健康产生积极影响的治疗方法基于正念的音乐疗法（MBMT）融合了癌症幸存者的核心要素。正念和量身定制的音乐干预组件（例如歌曲创作、乐器演奏）由我们训练有素的音乐治疗师团队已证明 (a) MBMT 可以减少负面情绪、疲劳、乳腺癌幸存者的焦虑和焦虑，(b) 压力管理和正念改善生理各种癌症幸存者群体中的调整（例如减少炎症）和 HRQoL，以及 (c) 电子医疗平台可以促进对癌症患者和幸存者的心理社会干预的有效实施。然而，研究实施了开发和评估精心设计的、可行的、可接受的、可重复的电子医疗促进 MBMT (eMBMT) 干预措施改善患者治疗效果的能力有限。此外，具体的音乐治疗成分如何影响社交（例如焦虑、抑郁）和生理（例如炎症、免疫能力）机制尚不清楚。凭借混合方法、电子医疗、allo-SCT 和 MBMT 方面的专业知识，我们解决了这些差距并建议确定新型电子医疗促进 eMBMT 在减轻症状方面的可接受性、可行性和预期效果负担并改善 HRQoL（主要结果），改善心理社会和生理适应，（例如，癌症困扰、炎症减轻、T 细胞恢复/免疫重建）（eMBMT 机制）、以及改善接受同种异体 SCT 的患者的疾病活动性（例如 GVHD）（次要结果）。 R61 阶段我们实施混合方法（例如焦点小组、小型 RCT）设计来最终确定 eMBMT 和正念冥想（eMM）控制条件，建立可行性并开始确定音乐疗法在我们的 R33 阶段，我们进行了更大规模的研究。基于 R61 研究结果的试点随机对照试验 (RCT) 旨在确定 eMBMT 音乐治疗成分的预期效果 HRQOL、症状负担以及社会心理和生理适应的研究结果将指导大规模随机对照试验。长期随访和额外的临床结果。