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.

患有镰状细胞病(SCD)的人在他们的一生中经常遭受多种急性疼痛危机。这些危机和身体并发症的累积影响导致在青春期早期出现慢性疼痛综合征、心理健康状况和与健康相关的生活质量受损，并持续到成年。在2020年SCD疼痛管理指南中，美国血液病学会承认了药理学方法的有限有效性，以及音乐疗法(MT)等非药理学综合方法的潜在好处。这些指南确定了研究重点，包括确定哪些非药物治疗是最可接受的，以及开发针对慢性SCD疼痛的手工化、可获得性和适合发展的干预措施。在我们先前的单部位可行性研究中，24名患有SCD和慢性疼痛的成年人被随机分为两组，一组接受面对面6次MT干预(n=12)，另一组接受等候名单对照(WLC)(n=12)。在这项随机对照试验(RCT)中，我们制定了筛选、招募、保留和电子数据收集的程序。注册率为89%，所有研究措施都完成了，MT参与者表现出100%的出勤率，并且与WLC参与者相比，他们在自我效能和HRQL方面有了改善。虽然这项随机对照试验的结果是有希望的，但要扩大干预范围，为未来的多地点、务实、明确的随机对照试验做准备，还需要采取进一步的步骤。此外，随着MT越来越适合于虚拟交付，包括在患有SCD的成年人中，需要进行试验，以调查混合方法(即，一个面对面和五个虚拟会话)交付MT的可行性。在这份R01中，我们建议研究一项多地点研究的可行性，包括(1)面对面MT(n=30)，(2)混合MT(n=30)，和(3)混合健康教育(Healed)(n=30)。我们的提案包括加州大学欧文分校的多个MUSIQOLS数据协调中心和两个招聘网站：大学医院/凯斯西储大学和普里斯玛健康/南卡罗来纳大学。总共90名受试者将被随机分为面对面MT、混合型MT或混合型健康教育(Healed)(1：1：1分配)，重点关注数据收集、参与者招募、提供干预措施和家庭实践的可行性。我们的具体目标是：目标1)开展可行性随机对照研究，以全面和跨两个地点检查数据收集过程和干预措施(面对面MT、混合MT和混合健康干预)的实施情况；以及目标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)来评估面对面MT、混合MT和混合健康干预措施的实施情况。拟议的可行性随机对照试验的成功进行将为与健康教育相比进行未来的、多地点的、务实的、有针对性的随机对照试验提供必要的框架。建议的R01及其后的随机对照试验(UG3/UH3)完成后，可提供重要证据，支持把MT列为SCD患者及其他类似人群的慢性疼痛干预措施。