Work

Protocol for Fit4Transplant: iterative optimisation of an exercise prehabilitation service for haematological cancer patients using phase II adaptive trials and co-design

Year: 2025

Type: conference-abstract

Abstract: BACKGROUND: Hematopoietic stem cell transplantation is a critical intensive treatment option for many people with haematological cancer but often leads to long-term reductions in physical function. Exercise-based prehabilitation can help to mitigate these effects and improve wellbeing. This study aims to evaluate and iteratively refine co-designed enhancements to an existing exercise-prehabilitation service. METHOD: Two intervention packages will be evaluated in sequential single-arm Bayesian optimal phase II adaptive trials. Package 1 will include two staff training modules (focused on trauma-informed service delivery and delivering engaging exercise classes online) and a behaviour Change booklet for patients. Package 2 will include refined (if necessary) Package 1 components, as well as an interactive self-management website/mobile application for patients. Outcome assessments will be conducted at baseline and post-intervention. The rate of promising response (a composite efficacy and acceptability outcome) in each trial will be monitored with interim analyses after 30 participants have completed post-intervention assessments. The intervention will be ceased prior to reaching the recruitment target (n = 60) if inadequate promising responses are observed (≥ 11 participants not meeting promising response criteria). A sub-sample of participants will also be invited to participate in an interview regarding stakeholder experiences delivering and receiving the intervention packages. Recruitment will commence in February 2025. DISCUSSION: This sequential adaptive design allows trialling a simpler intervention while the digital component is finalised, with iterative refinements guided by interim analyses and co-design. The outcomes of this study will help inform future prehabilitation programs involving exercise programs and provide an example of how co-design and adaptive trials can be combined to optimise behavioural health interventions within routine care. TRIAL REGISTRATION: Australian NewZealand Clinical Trial Registry ACTRN12624000363583p. Registered 28th March 2024.

Source: BMC Cancer

DOI: 10.1186/s12885-025-15027-6