Developing a P01 to Address Cognitive Impairment and Treatment Tolerability in Patients with Advanced Cancer - ABSTRACT This application entitled “Developing a P01 to Address Cognitive Impairment and Treatment Tolerability in Patients with Advanced Cancer” is being submitted in response to “Administrative supplements to advance development of transdisciplinary and large-scale population science and cancer control research projects. This application is led by 3 internationally renowned experts (Drs. Janelsins, Mohile, Mustian) in the fields of cancer-related cognitive impairment (CRCI), tolerability, geriatric oncology, and exercise oncology, with over 75 collaborative publications. The goal of this supplement is to provide the resources for planning a successful large-scale, synergistic program project application. People living with advanced cancer are unique and different from patients treated for early-stage disease, as they often have complex medical trajectories and treatment plans, leading to ongoing supportive care needs due to incurable disease. CRCI is one of the most prevalent and burdensome complications, affecting many patients with advanced cancer. Our ultimate goal is to submit a P01 application that addresses and intervenes on CRCI to improve treatment tolerability. Specifically, our team plans to develop P01 projects to better understand the experience of CRCI in patients with advanced cancer. Our team will also develop P01 projects to test novel exercise and diet interventions to improve CRCI and treatment tolerability. This research aligns with NCI and Division of Cancer Control and Population Science (DCCPS) priorities. Our proposed research specifically addresses NCI’s Notice of Special Interest: Survivorship Research for People Living with Advanced and Metastatic Cancers (NOT-CA-25-024) and PAR-23-059. This research also aligns with the priorities of Wilmot Cancer Institute, NCI’s newest designated cancer center (P30CA272302). The MPIs have identified potential Project PIs; this team has been meeting for the past two years to understand our multi-disciplinary expertise, brainstorm, and conduct initial literature reviews and pilot studies. This supplement is perfectly timed to refine our P01 research projects, synergy, and methods. Our supplement objectives include: 1) identify and finalize key research team members, cores, and infrastructure, 2) conduct preliminary research to finalize an integrated biological model related to CRCI and interventions, and 3) finalize an overarching theoretical framework, synergy, and research projects. Key deliverables include finalized: 1) Project PIs/MPIs, 2) EAB members, 3) cores, 4) infrastructure partnerships, 5) biological signatures and integrated model, 6) overall theoretical framework, 7) synergy map, 8) 3-4 research projects, 9) NCI pre-submission meeting, and 10) new preliminary data publications. We are confident that we will meet these deliverables and submit our application in September, 2026.
