Denehy Linda, Abo Shaza, Swain Christopher, Short Camille E, Kiss Nicole, Khot Amit, Wong Eric, Purtill Duncan, O'Donnell Clare, Klaic Marlena, Granger Catherine L, Tew Michelle, Spelman Tim, Cavalheri Vinicius, Edbrooke Lara
Department of Physiotherapy, The University of Melbourne, 161 Barry Street, Parkville, VIC, 3010, Australia.
Department of Health Services Research, Peter Maccallum Cancer Centre, 305 Grattan Street, Melbourne, VIC, 3000, Australia.
BMC Cancer. 2025 Mar 24;25(1):532. doi: 10.1186/s12885-025-13898-3.
Haematological cancer affects more than 1.3 million people around the world annually and accounted for almost 800,000 deaths globally in 2020. The number of patients with these cancers undergoing bone marrow transplant is increasing. Of note, this intensive treatment is associated with complex and multifactorial side effects, often impacting nutritional status, physical functioning and overall health-related quality of life. The primary aim of this study is to investigate the effectiveness of an eight-week multidisciplinary rehabilitation intervention compared with usual care on the physical function domain of the European Organisation for the Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30 version 3) in patients with haematological cancer following bone marrow transplant.
This is a multisite, pragmatic two-arm parallel-group, randomised controlled trial (RCT) with stratified randomisation, powered for superiority, recruiting 170 participants at 30 days following either allogeneic or autologous bone marrow transplant (ACTRN12622001071718). Recruitment sites include three Australian university affiliated teaching hospitals. Participants are eligible if aged ≥ 18 years, treated for haematological cancer with allogeneic or autologous bone marrow transplant and can walk independently. The intervention group will receive eight weeks of twice weekly telehealth-based exercise classes, an initial and follow up dietetics consult, post exercise protein supplements, and a home-based physical activity program, all with embedded behaviour change strategies. The primary outcome is patient reported physical function measured using the EORTC QLQ-C30 version 3. Secondary outcomes include other domains of the EORTC QLQ-C30, fatigue, physical function, physical activity levels, frailty, body composition, sarcopenia and nutrition assessment. We will also undertake a health economic analysis alongside the trial and a process evaluation exploring intervention fidelity, causal mechanisms as well as contextual influences through qualitative enquiry.
The REBOOT trial will add RCT-evidence from a rigorously conducted, statistically powered multi-site trial to existing limited knowledge on the effects of multi-disciplinary rehabilitation for people with haematological cancer. If effectiveness is supported, then implementation of rehabilitation into care pathways for people having bone marrow transplant can be considered.
ACTRN12622001071718 prospectively registered 03/08/2022, last updated 08/03/2024.
血液系统癌症每年影响全球超过130万人，2020年全球死亡人数近80万。接受骨髓移植的这类癌症患者数量正在增加。值得注意的是，这种强化治疗会带来复杂且多因素的副作用，常常影响营养状况、身体功能以及与整体健康相关的生活质量。本研究的主要目的是调查与常规护理相比，为期八周的多学科康复干预对骨髓移植后血液系统癌症患者欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-C30第3版）身体功能领域的有效性。
这是一项多中心、实用的双臂平行组随机对照试验（RCT），采用分层随机化，具有优越性检验效能，在同种异体或自体骨髓移植后30天招募170名参与者（澳大利亚新西兰临床试验注册中心编号：ACTRN12622001071718）。招募地点包括三家澳大利亚大学附属教学医院。年龄≥18岁、接受过同种异体或自体骨髓移植治疗血液系统癌症且能独立行走的参与者符合条件。干预组将接受为期八周、每周两次的基于远程医疗的运动课程、一次初始和一次随访的营养咨询、运动后蛋白质补充剂以及一项居家身体活动计划，所有这些都嵌入了行为改变策略。主要结局是使用EORTC QLQ-C30第3版测量的患者报告的身体功能。次要结局包括EORTC QLQ-C30的其他领域、疲劳、身体功能、身体活动水平、虚弱、身体成分、肌肉减少症和营养评估。我们还将在试验期间进行卫生经济学分析，并通过定性调查进行过程评估，探索干预的保真度、因果机制以及背景影响。
REBOOT试验将为现有关于血液系统癌症患者多学科康复效果的有限知识增添来自严格开展、具有统计学效能的多中心试验的RCT证据。如果有效性得到证实，那么可以考虑将康复纳入骨髓移植患者的护理路径。
ACTRN12622001071718于2022年8月3日前瞻性注册，最后更新于2024年3月8日。
