This pilot study will evaluate the feasibility of implementing a structured digital patient-reported assessment pathway in adults aged 65 years or older with acute leukemia. Following activation of the institutional MiAsturSalud/SESPA platform, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit and will repeat the digital assessment at 3-6 months. The primary outcome will be completion of at least 80% of the baseline digital assessment within 7 days. Secondary outcomes will be caregiver assistance requirement, non-completion of the planned digital follow-up assessment, and elapsed completion time. The study is not designed to establish clinical efficacy.
Age 65 years or older.
Confirmed diagnosis of acute leukemia of myeloid or lymphoid origin.
Active ambulatory follow-up in the Hematology Service at Hospital Universitario Central de Asturias.
Ability to understand the questionnaires and provide their own responses, independently or with practical assistance from a caregiver.
Cognitive impairment that, in the treating hematologist's clinical judgment, prevents the participant from understanding the questionnaires or providing their own responses, despite permitted practical assistance from a caregiver.
Clinical condition that, in the treating hematologist's judgment, precludes completion of the study procedures.
Persistent inability to access or use the MiAsturSalud/SESPA platform despite reasonable technical support.
Fundación para la Investigación Biosanitaria del Principado de Asturias
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborator