Development of a multi-modal PeRsOnalised PrEhabilitation intervention for people with acute myeloid Leukaemia: the PROPEL trial

<ns5:p> Background Acute Myeloid Leukaemia affects approximately 3,100 people annually in the UK. Individuals with high-risk myelodysplastic syndrome (MDS-EB2) receive similar treatment. Curative-intent therapy involves multiple courses of chemotherapy and may include haematopoietic stem cell transplant (HSCT). Treatment tolerance is challenging, with fatigue, muscle loss, poor appetite, and impaired psychological wellbeing common. Prehabilitation may support physical and psychological health, improving treatment tolerance, recovery, fatigue, quality of life, and survival. However, no standardised prehabilitation programme exists for AML/MDS-EB2 within the UK National Health Service. This paper describes the development of a comprehensive, multimodal prehabilitation intervention for individuals with AML and MDS-EB2. Methods The intervention was developed using a theory- and evidence-based approach, underpinned by behavioural science and Acceptance and Commitment Therapy principles. Given limited AML/MDS-EB2-specific prehabilitation literature, development was informed by the wider cancer prehabilitation evidence base. A multidisciplinary team, including patients and carers, followed the Medical Research Council framework for complex intervention development. Guiding principles prioritised patient preferences and minimised delivery burden. A needs assessment included research priority setting, stakeholder engagement, scoping reviews, and surveys of patients and healthcare professionals. Components addressing emotional wellbeing, nutrition, exercise, and behavioural support were developed through literature review, adaptation of existing interventions and guidelines, and extensive patient and carer input. Training materials were developed and intervention delivery rehearsed. Results The intervention includes a multimodal personalised prehabilitation care plan (PPCP) including emotional wellbeing, nutrition, and exercise, as required following assessment, with embedded behavioural support. It is designed to be delivered remotely, as part of consolidation chemotherapy and or HSCT. Conclusions We developed a multi-component, multi-phasic, PPCP for individuals receiving remission consolidation treatment for AML/MDS-EB2 in the PROPEL trial. Patient input was extensive. The PROPEL intervention is being tested in a two-arm multi-centre UK-based phase III trial with internal pilot and embedded process and economic evaluations. <ns5:bold>Trial registration:</ns5:bold> ISRCTN Registry 17655532; Registration date: 26/05/2023. PROPEL trial opened September 2023; trial end date August 2027. </ns5:p>