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Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
Sponsor: Fundación para la Investigación Biosanitaria del Principado de 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 at Hospital Universitario Central de Asturias, Oviedo, Spain. Participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit and repeat the digital assessment 8-12 weeks after individual activation of the MiAsturSalud/SESPA digital pathway. The primary outcome will be the proportion of participants answering at least 80% of the items in the baseline digital questionnaire battery within 7 days after the baseline visit. Secondary outcomes will be caregiver assistance requirement, non-completion of the planned digital follow-up assessment, and elapsed baseline questionnaire completion time. During this feasibility study, participants will not concurrently receive the broader project's home-monitoring and clinical-alert intervention. The questionnaire pathway will not generate automated clinical alerts. Usual clinical care will continue. The study is not designed to establish clinical efficacy.
Official title: Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-12
Completion Date
2028-03
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Digital Patient-Reported Assessment Pathway
Following individual activation of the MiAsturSalud/SESPA digital pathway, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely. The baseline assessment will be scheduled 48-72 hours after the baseline visit, with a primary outcome assessment window extending to 7 days after that visit. A second digital assessment will be scheduled 8-12 weeks after individual pathway activation. The platform will permit skipped items, save partial responses, and allow participants to resume the baseline assessment within the 7-day window. Questionnaire item responses and timing data will be recorded, and practical caregiver assistance will be documented. The questionnaire pathway will not generate automated clinical alerts or mandate treatment changes. Participants will not concurrently receive the broader project's home-monitoring and clinical-alert intervention during this feasibility study. Usual clinical care will continue.
Locations (1)
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, Spain