背景:评估多学科的康复策略对于先发制人地对抗身体,急性髓系白血病(AML)和骨髓增生异常综合征(MDS)患者的异基因造血干细胞移植(allo-HSCT)过程中经历的心理和社会负面影响。目前的证据仅限于诱导化疗期间的研究,省略康复干预措施,主要使用仅运动的方法,而没有多学科框架。这项研究的目的是探讨可行性,成人多学科康复的安全性和初步疗效提供allo-HSCT。
方法:这项为期8周的单组可行性研究旨在为接受allo-HSCT的参与者试行多学科康复干预,注重可行性和安全性。参与者,18岁或以上,诊断为AML或MDS,并提供allo-HSCT,将在2023年6月至2024年7月期间招募。多学科康复干预,由皇家阿德莱德医院的癌症专职医疗小组进行,包括运动生理学,物理治疗,营养学,社会工作,职业治疗和心理干预。与多学科治疗方法一致,每个组件都是针对患者护理的不同方面量身定制的,和依从性计算将评估患者的参与度和依从性。此外,参与者将继续接受癌症专职医疗人员的常规护理。该研究的主要结果是通过评估干预措施的吸收来评估多学科康复干预的可行性。保留,坚持,可接受性和安全性。次要结果是腿部力量,上身强度,有氧健身,跌倒风险,人体测量学,营养状况,生活质量,焦虑,抑郁症,应对癌症和痛苦的自我效能感。
背景:本研究的伦理批准已由阿德莱德中央地方卫生网络(HREC2022/HRE00284)提供。该研究的招聘始于2023年6月,并将持续到2024年7月。这些方法已根据SPIRIT和CONSORT试点研究清单进行了设计和报告。
背景:澳大利亚新西兰临床试验注册中心(ANZCTR):ACTRN12623000052639。
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: 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.
BACKGROUND: 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.
BACKGROUND: The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000052639.