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NCT07597590
Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
Conditions: Leukemia Acute Myeloid, Leukemia Acute Lymphoid Leukemia (ALL)
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Fundación para la Investigación Biosanitaria del Principado de Asturias
Location: Hospital Universitario Central de Asturias (HUCA) Oviedo Principality of Asturias
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
* Access to a compatible internet-enabled digital device, either personally or through a caregiver.
* Provision of written informed consent.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07597590). StuddyBuddy aggregates publicly available trial information.