Nurse AMIE randomized controlled trial to address symptom management among rural advanced Cancer patients: Addressing malignancies in everyday life

Background: Assessing and managing symptoms has a survival benefit for patients with advanced cancer. However, rural cancer patients have difficulty accessing services to address symptoms. Technology may offer one solution; however, little work has been done to specifically leverage technology-based solutions to deliver high quality supportive care in rural settings. Methods: Nurse AMIE (Addressing Malignancies in Individuals Everyday) is a 2-year, Phase III randomized controlled efficacy trial to investigate the use of a tablet-based symptom management and supportive care intervention to improve overall survival among 344 advanced cancer patients living in rural areas. Participants are randomized on a 1:1 basis to the Nurse AMIE intervention or a usual care group that receives a binder with written supportive care materials. Intervention participants are asked to access the Nurse AMIE application daily using the study-provided tablet to answer symptom questionnaires regarding their level of pain, fatigue, sleep, and distress. After receiving an empathic response from Nurse AMIE, participants are offered a guideline concordant self-care intervention to address their symptoms. The trial is powered to detect a 19 % difference in overall survival between groups at 2 years. Secondary outcomes include symptom severity, function, quality of life, patient-reported outcomes, and cost-effectiveness. Conclusions: Nurse AMIE is the first trial to apply and rigorously assess the effect of ongoing symptom assessment and management on overall survival among rural, advanced cancer patients. Results from the Nurse AMIE trial will provide evidence of the efficacy of delivering a high-quality, technology-based supportive care program among underserved rural populations. ClinicalTrials.gov