MULTIsite feasibility of MUSIc therapy to address Quality Of Life in Sickle cell disease (MULTI-MUSIQOLS)

MUSIC 疗法解决镰状细胞病生活质量问题的多部位可行性 (MULTI-MUSIQOLS)

• 批准号: 10728452
• 负责人: Jeffery A Dusek
• 金额: $ 60.96万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-18 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10728452
• 关键词: Acute Pain; Address; Adoption; Adult; American Society of Hematology; Anxiety; COVID-19 pandemic; California; Cancer Center; Chronic; Clinic; Collaborations; Control Groups; Data; Data Collection; Data Coordinating Center; Development; Education; Educational Intervention; Effectiveness; Enrollment; Etiology; Feasibility Studies; Future; Goals; Guidelines; Health Personnel; Health education; Home; Hybrids; Impaired health; Individual; Intervention; Interview; Longevity; Manuals; Measures; Mental Health; Music; Music Therapy; Nonpharmacologic Therapy; Pain; Pain Management Method; Pain interference; Pain management; Participant; Patient Recruitments; Patients; Persons; Pilot Projects; Population; Preparation; Procedures; Process; Protocols documentation; Provider; Quality of life; Randomized; Randomized, Controlled Trials; Records; Research; Research Priority; Research Project Grants; Screening procedure; Self Efficacy; Sickle Cell Anemia; Site; Sleep disturbances; Social Functioning; South Carolina; Structure; Surveys; Syndrome; Therapeutic Intervention; Universities; University Hospitals; Waiting Lists; chronic pain; chronic pain management; comparison group; data quality; early adolescence; electronic data; feasibility research; health related quality of life; implementation evaluation; implementation facilitators; implementation outcomes; implementation process; improved; intervention delivery; participant retention; pharmacologic; prisma; programs; psychosocial; public health relevance; randomized trial; recruit; response; success; virtual; virtual delivery

Individuals with sickle cell disease (SCD) often endure multiple acute pain crises throughout their lives. The cumulative impact of these crises and physical complications contribute to the emergence of chronic pain syndromes, mental health conditions, and impaired health-related quality of life (HRQoL) in early adolescence that persist through adulthood. In their 2020 pain management guidelines for SCD, the American Society of Hematology acknowledged the limited effectiveness of pharmacologic approaches and the potential benefits of nonpharmacologic integrative approaches such as music therapy (MT). These guidelines identified research priorities including determining which nonpharmacologic therapies are most acceptable and developing manualized, accessible, and developmentally appropriate interventions for chronic SCD pain. In our prior single-site feasibility study, 24 adults with SCD and chronic pain were randomized to receive either an in-person 6-session MT intervention (n = 12) or waitlist control (WLC) (n = 12). We developed procedures for screening, recruitment, retention, and electronic data collection within this randomized controlled trial (RCT). The enrollment rate was 89%, all study measures were completed, and MT participants demonstrated 100% attendance as well as improvements in self-efficacy and HRQoL compared to WLC participants. While results from this pilot RCT are promising, to scale an intervention in preparation for a future, multi-site, pragmatic, definitive RCT, further steps are needed. Furthermore, with MT being increasingly adapted for virtual delivery, including among adults with SCD, trials are needed to investigate the feasibility of hybrid (i.e., one in-person and five virtual sessions) approaches to MT delivery. In this R01, we propose to examine the feasibility of a multi-site study enrolling (1) in-person MT (n=30), (2) hybrid MT (n=30), and (3) hybrid Health Education (HealthEd) (n=30). Our proposal includes the MULTI-MUSIQOLS Data Coordinating Center at University of California Irvine and two recruiting sites: University Hospitals/Case Western Reserve University and Prisma Health/University of South Carolina. A total of 90 subjects will be randomized to either in-person MT, hybrid MT, or hybrid Health Education (HealthED) (1:1:1 allocation) with a focus on feasibility of data collection, participant recruitment, delivery of interventions, and home practice. Our Specific Aims are: AIM 1) conduct a feasibility RCT to examine the data collection processes and intervention (in-person MT, hybrid MT, and hybrid HealthED) implementation overall and across 2 sites; and AIM 2) evaluate the implementation of the in-person MT, hybrid MT, and hybrid HealthED interventions using both quantitative data (study records, stakeholder surveys) and qualitative data (interviews). Successful conduct of the proposed, feasibility RCT will provide the necessary framework for conducting a future, multi-site, pragmatic, RCT of MT compared with HealthED. Completion of the proposed R01 and the subsequent RCT (UG3/UH3) could provide critical evidence to support inclusion of MT as a chronic pain intervention for individuals with SCD and other similar populations.

镰状细胞病 (SCD) 患者一生中常常会经历多次急性疼痛危机。这些危机和身体并发症的累积影响导致青春期早期出现慢性疼痛综合征、心理健康状况和健康相关生活质量 (HRQoL) 受损，并持续到成年期。美国血液学会在其 2020 年 SCD 疼痛管理指南中承认药物方法的有效性有限，以及音乐疗法 (MT) 等非药物综合方法的潜在益处。这些指南确定了研究重点，包括确定哪些非药物疗法最可接受，以及开发针对慢性 SCD 疼痛的手动、易于使用且适合发育的干预措施。在我们之前的单中心可行性研究中，24 名患有 SCD 和慢性疼痛的成年人被随机分配接受 6 次面对面 MT 干预 (n = 12) 或等待名单控制 (WLC) (n = 12)。我们在这项随机对照试验 (RCT) 中制定了筛选、招募、保留和电子数据收集程序。入学率为 89%，所有研究措施均已完成，与 WLC 参与者相比，MT 参与者表现出 100% 的出勤率以及自我效能感和 HRQoL 的改善。虽然这项试点随机对照试验的结果很有希望，但为了扩大干预范围，为未来的多中心、务实、明确的随机对照试验做准备，还需要采取进一步的措施。此外，随着机器翻译越来越适应虚拟交付，包括在患有 SCD 的成年人中，需要进行试验来调查混合（即 1 次面对面会议和 5 次虚拟会议）方法进行 MT 交付的可行性。在本 R01 中，我们建议检查一项多中心研究的可行性，该研究招募 (1) 面对面 MT (n=30)、(2) 混合 MT (n=30) 和 (3) 混合健康教育 (HealthEd) ）（n=30）。我们的提案包括加州大学欧文分校的 MULTI-MUSIQOLS 数据协调中心和两个招募地点：大学医院/凯斯西储大学和 Prisma Health/南卡罗来纳大学。总共 90 名受试者将被随机分配到现场 MT、混合 MT 或混合健康教育 (HealthED)（1:1:1 分配），重点关注数据收集、参与者招募、干预措施实施和实施的可行性。家庭练习。我们的具体目标是： AIM 1) 进行可行性随机对照试验，以检查整个数据收集流程和干预措施（现场 MT、混合 MT 和混合 HealthED）在 2 个站点的实施情况； 2) 使用定量数据（研究记录、利益相关者调查）和定性数据（访谈）评估现场 MT、混合 MT 和混合 HealthED 干​​预措施的实施情况。与 HealthED 相比，拟议的可行性随机对照试验的成功实施将为未来开展多地点、务实的 MT 随机对照试验提供必要的框架。完成拟议的 R01 和随后的 RCT (UG3/UH3) 可以提供关键证据，支持将 MT 作为 SCD 患者和其他类似人群的慢性疼痛干预措施。