Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

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.

NCT Number	NCT07597590
Lead Sponsor	Fundación para la Investigación Biosanitaria del Principado de Asturias Collaborators: Otsuka Pharmaceutical Co., Ltd.
Conditions	Leukemia Acute Myeloid, Leukemia Acute Lymphoid Leukemia (ALL)
Enrollment	20 participants
Start Date	2026-12
Primary Completion	2027-12 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-06