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调查多学科预康复对适合异体造血干细胞移植患者去适应不良的影响:一项可行性试验方案。

Investigating the impact of multidisciplinary prehabilitation on deconditioning in patients eligible for haematopoietic allogenic stem cell transplantation: protocol for a feasibility trial.

机构信息

Royal Adelaide Hospital, Adelaide, South Australia, Australia.

University of South Australia, Adelaide, South Australia, Australia

出版信息

BMJ Open. 2024 Sep 5;14(9):e084372. doi: 10.1136/bmjopen-2024-084372.

Abstract

BACKGROUND

Assessing multidisciplinary prehabilitation strategies becomes crucial to pre-emptively counter the physical, psychological and social negative impacts experienced during an allogenic haematopoietic stem cell transplant (allo-HSCT) among acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) patients. Current evidence is restricted to studies during induction chemotherapy, omitting rehabilitation interventions and predominantly using exercise-only approaches without a multidisciplinary framework. The aim of this study is to investigate the feasibility, safety and preliminary efficacy of multidisciplinary prehabilitation in adults offered allo-HSCT.

METHODS AND ANALYSIS

This 8-week single-group pre-post feasibility study aims to pilot a multidisciplinary prehabilitation intervention for participants undergoing allo-HSCT, with a focus on feasibility and safety. Participants, aged 18 or older, diagnosed with AML or MDS, and offered allo-HSCT, will be recruited between June 2023 and July 2024. The multidisciplinary prehabilitation intervention, conducted by the cancer allied health team at the Royal Adelaide Hospital, includes exercise physiology, physiotherapy, dietetics, social work, occupational therapy and psychology interventions. Consistent with a multidisciplinary treatment approach, each component is tailored to address different aspects of patient care, and adherence calculations will assess patient engagement and compliance. In addition, participants will continue to receive usual care from cancer allied health staff. The primary outcome of the study is to assess the feasibility of a multidisciplinary prehabilitation intervention by evaluating intervention uptake, retention, adherence, acceptability and safety. Secondary outcomes are leg strength, upper-body strength, aerobic fitness, falls risk, anthropometry, nutritional status, quality of life, anxiety, depression, self-efficacy for coping with cancer and distress.

ETHICS AND DISSEMINATION

Ethics approval for this study has been provided by the Central Adelaide Local Health Network (HREC 2022/HRE00284). Recruitment for the study commenced in June 2023 and will continue until July 2024. The methods have been designed and are reported according to the SPIRIT and CONSORT-pilot study checklist.

TRIAL REGISTRATION NUMBER

The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000052639.

摘要

背景

评估多学科预康复策略对于预防急性髓细胞白血病 (AML) 和骨髓增生异常综合征 (MDS) 患者接受同种异体造血干细胞移植 (allo-HSCT) 期间经历的身体、心理和社会负面影响至关重要。目前的证据仅限于诱导化疗期间的研究,忽略了康复干预措施,并且主要使用没有多学科框架的仅运动方法。本研究的目的是调查多学科预康复在接受 allo-HSCT 的成年人中的可行性、安全性和初步疗效。

方法和分析

这是一项为期 8 周的单组前后可行性研究,旨在为接受 allo-HSCT 的患者试行多学科预康复干预,重点关注可行性和安全性。参与者年龄在 18 岁或以上,诊断为 AML 或 MDS,并接受 allo-HSCT,将于 2023 年 6 月至 2024 年 7 月期间招募。多学科预康复干预由阿德莱德皇家医院的癌症联合健康团队进行,包括运动生理学、物理治疗、营养学、社会工作、职业治疗和心理学干预。与多学科治疗方法一致,每个组成部分都经过精心设计,以解决患者护理的不同方面,并且通过依从性计算评估患者的参与度和依从性。此外,参与者将继续接受癌症联合健康工作人员的常规护理。该研究的主要结果是通过评估干预的接受率、保留率、依从性、可接受性和安全性来评估多学科预康复干预的可行性。次要结果是腿部力量、上肢力量、有氧健身、跌倒风险、人体测量学、营养状况、生活质量、焦虑、抑郁、应对癌症的自我效能感和困扰。

伦理和传播

该研究已获得中央阿德莱德当地卫生网络 (HREC 2022/HRE00284) 的伦理批准。该研究的招募工作已于 2023 年 6 月开始,将于 2024 年 7 月结束。方法是根据 SPIRIT 和 CONSORT-预试验清单进行设计和报告的。

试验注册

澳大利亚和新西兰临床试验注册中心 (ANZCTR):ACTRN12623000052639。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7624/11381652/00104cec2069/bmjopen-14-9-g001.jpg

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