MOTIVATE: Feasibility Challenges and Protocol Adaptation Within a Pilot Randomized Rehabilitation Trial for Individuals With Multiple Myeloma
Leslie P. Ternes, Stephanie Bernard, Puneeta Tandon, Carla Prado, Nanette Cox-Kennett, Irwindeep Sandhu, Joanne Hewitt, Michael Chu, Edith Pituskin, Graeme Purdy, Naomi Dolgoy, Margaret L. McNeelyBackground:
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.
Methods:
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.
Conclusion:
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.