MOTIVATE: Feasibility Challenges and Protocol Adaptation Within a Pilot Randomized Rehabilitation Trial for Individuals With Multiple Myeloma

Abstract

Multiple myeloma (MM) is an incurable cancer of the plasma cells. Although survival has improved, individuals with MM continue to experience treatment-related symptoms and functional decline. Autologous stem cell transplant (SCT) helps participants attain longer disease-free periods but requires a base level of fitness to proceed safely. Prior work by our group has identified substantial patient-reported barriers to exercise in the pre-SCT setting and highlighted a preference for tailored, flexible, and hybrid exercise delivery models to support participation. The aim of this trial protocol is to evaluate the feasibility of a tailored exercise rehabilitation program delivered using a hybrid model that supports virtual, in-person, or combined participation. The trial was originally limited to transplant-eligible individuals before SCT but, due to low recruitment, was amended to include transplant-ineligible and post-SCT individuals. This randomized feasibility trial uses 1:2 allocation to standard care or intervention. A minimum of 30 participants will be recruited and stratified by transplant status. The supervised exercise program is delivered over 8-to-12 weeks using in-person, virtual, or hybrid formats. Feasibility outcomes include recruitment, retention, adherence, and safety. Exploratory efficacy outcomes include physical fitness, patient-reported outcomes, and optional thigh ultrasound measures. The trial will inform the feasibility of delivering tailored rehabilitation across diverse MM clinical pathways to inform future research. Importantly, we highlight how real-world recruitment challenges may necessitate adaptive trial design in rehabilitation oncology.