Nurse AMIE: Addressing symptoms in rural patients with advanced cancer.

Abstract

TPS12148 Background: Prior research has shown that monitoring symptoms in advanced cancer patients may provide a survival benefit. Monitoring is a labor-intensive process that requires nursing staff response and visiting a medical office. This may be more challenging in rural areas, given staffing challenges and distances traveled for care. Lower density of supportive care services has been documented in rural as compared to urban settings in Pennsylvania and West Virginia. We have developed a computer tablet-based supportive care program, called Nurse AMIE, and are investigating its use in symptom management among cancer survivors. Our hypothesis is that a tablet-based supportive care program can improve overall survival of advanced cancer patients in rural Pennsylvania and West Virginia. Methods: This randomized controlled trial will recruit 344 patients residing in a rural county or zip code (RUCC 4-9 or RUCA 4-10) in Pennsylvania or West Virginia, who receive treatment for stage III-IV cancer, are 18 years or older, ECOG 0-3, are fluent in written and spoken English, have sufficient vision/hearing to interact with a computer tablet and staff, and have a clinician-defined life expectancy of 6 months or more. Exclusion criteria: patients on active treatment or behavioral or supportive care trials, or with medical or psychiatric conditions that would impair ability to test study hypotheses. Patients will be randomized on a 1:1 basis to receive either Nurse AMIE or a binder with written supportive care materials. Intervention participants will be asked to log into Nurse AMIE daily, where they will interact with a nurse avatar and answer symptom questions (focusing on sleep, fatigue, pain, and distress). They will receive an empathic response to symptoms and be offered evidence based, guideline concordant self-care interventions to address symptoms (including exercise, nutrition, guided meditation, cognitive behavioral therapy videos, and soothing music). Once weekly, patients will answer 21 questions from the Pro-CTCAE survey. All symptom data will be loaded into a dashboard reviewed daily by study staff. Pain or distress scores of 7+ (out of 10) will be communicated to the care team through the EMR. The trial is powered to detect a 19% difference in overall survival at 2 years follow-up (based on Denis et al JAMA 2019). Secondary outcomes include incidence of chemotherapy toxicities, patient reported outcomes, and cost effectiveness. Enrollment is anticipated to start in March 2022. A community advisory board of 12 cancer patients and stakeholders meet on a quarterly basis to provide feedback on study activities (e.g., usability testing, adaptations, overall implementation) and ensure the project responds to the needs and preferences of rural cancer patients in Pennsylvania and West Virginia. NIH R01-CA254659. Clinical trial information: NCT05221606.