Abstract
PURPOSE: Those living beyond a cancer diagnosis experience unmet supportive care needs due to fragmented post-treatment pathways and limited integration of digital health tools. The Linking You to Support and Advice (LYSA) trial assessed the feasibility of a complex-intervention which incorporated a nurse- and dietitian-led multidisciplinary clinic and a digital platform for capturing and responding to electronic Patient-Reported Outcome (ePRO) data for women with early-stage breast and gynecologic cancer less than 12 months post-primary curative therapy. METHODS: The LYSA trial was an unblinded, randomized, controlled, feasibility trial co-designed with public and patient involvement, conducted across two cancer centers in Ireland. Participants were randomized to the experimental arm, receiving bi-monthly ePRO assessments and trigger-initiated responses to ePROs for 12 months; or the active comparator arm, receiving usual care. Primary feasibility outcomes included participant enrolment, ePRO survey completion, and healthcare professional engagement triggered by ePRO assessments. Secondary outcomes focused on symptom scores, health-related quality of life (HRQOL), and patient satisfaction. A process evaluation explored factors affecting implementation. RESULTS: The trial met its three predefined feasibility outcomes: 200 participants were enrolled (84% breast, 16% gynecologic), >85% of baseline and endpoint surveys were completed, and >70% of participants in the experimental arm engaged in nurse and dietetic consultations following ePRO symptom triggers. The experimental arm demonstrated significant improvements in fatigue (p = 0.018), anxiety (p = 0.012), depression (p < 0.001) and HRQOL (p = 0.031) scores. The process evaluation indicated high levels of satisfaction with the intervention, with positive feedback on the multidisciplinary approach and responsive symptom management. CONCLUSIONS: LYSA demonstrates the feasibility and acceptability of an ePRO-led survivorship approach, with potential HRQOL and symptom benefits, warranting a powered efficacy trial.