Feasibility of a structured digital patient-reported assessment pathway in older adults with acute leukaemia in Spain: protocol for a prospective single-centre, single-arm pilot study

Introduction: This pilot study will evaluate the feasibility of implementing a structured digital patient-reported assessment pathway in adults aged ≥65 years with acute leukaemia receiving ambulatory haematology follow-up. Participants will complete validated patient-reported outcome questionnaires remotely through the institutional MiAsturSalud/SESPA platform. The pathway will not constitute a comprehensive geriatric assessment or a treatment-modification intervention.

Methods and analysis: This prospective, longitudinal, single-centre, single-arm pilot feasibility study will be conducted at Hospital Universitario Central de Asturias, Oviedo, Spain. Recruitment of 20 participants is anticipated to begin in December 2026 after the digital pathway becomes operational. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Functional Assessment of Cancer Therapy–Leukaemia will be administered 48–72 hours after the baseline visit and again 8–12 weeks after individual pathway activation. The primary outcome will be the proportion of all enrolled participants answering at least 60 of the 74 baseline items (≥80%) within 7 days after the baseline visit. The platform will permit skipped items, save partial responses and allow resumption; completion will be assessed independently of formal submission. Secondary outcomes will be caregiver assistance, follow-up non-completion and elapsed time to the baseline completion threshold. Participants will not concurrently receive the broader project’s research home-monitoring and clinical-alert intervention. Analyses will be descriptive and exploratory, with an exact binomial 95% CI for the primary estimate.