User-centered design of a COPD care pathway for patients with cancer: a mixed-methods clinical trial protocol

Chronic obstructive pulmonary disease (COPD) is the most common comorbidity among patients being treated for any type of cancer with an immune checkpoint inhibitor in the medical oncology clinic. There is a critical need to measure the treatment burden of COPD and design a scalable intervention to optimize its care. Our primary aim is to determine the ideal design of a care pathway to optimize COPD in community oncology clinics. This mixed-methods study will collect data to quantify and understand the disease burdens, components of care, and barriers in the medical oncology clinic. As per user-centered design methodology, participants at design team workshops will then integrate these data into a COPD care pathway. This study will provide critical data on the impact of COPD upon patients with cancer and identify how its care can be optimized in the medical oncology clinic. These results will directly inform a novel care pathway that will be designed for scalability in the community setting. Future studies will test this pathway versus usual care in a cluster randomized controlled trial across a network of oncology clinics.<b>Clinical Trial Registration:</b> ClinicalTrials.gov NCT05984680.