Discussion
cancer, UC
CANCER, SEQUELAE, COMPLICATION
We conducted this proof-of-concept RCT to examine the feasibility, usability, and acceptability of the PRISMS—a multilevel eHealth symptom and complication monitoring and self-management program—for cancer patients with newly created ostomies and their caregivers. We also evaluated the preliminary efficacy of PRISMS on the health outcomes of patients and their caregivers. Findings from this study will guide the refinement of PRISMS and the study protocol for a sufficiently powered efficacy RCT.It is worth noting that this proof-of-concept pilot study was conducted in 2020–2021 and the COVID-19 pandemic may have affected the process and results. During this time, the number of COVID-19 cases fluctuated, particularly when the vaccine became available. Most UC participants were in the study when the number of positive COVID-19 cases decreased and the vaccinated population increased in North Carolina (between 3/17/21 and 8/1/21), whereas most PRISMS participants were in the study when the number of COVID-19 cases surged (before 3/17/21 or after 8/1/21). Participants in the PRISMS and UC groups may have experienced different levels of COVID-19-related physical, emotional, social, and functional sequelae that affected QOL and symptoms, but impossible to be teased out in this proof-of-concept study given the small sample size.