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Digital Structured Assessment in Older Patients With Acute Leukemia: Clinical Impact

NCT07597590 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-19

No results posted yet for this study

Summary

This pilot study evaluates the feasibility and preliminary clinical impact of digitally implementing a structured assessment in adults aged ≥65 years with acute leukemia receiving ambulatory follow-up care. Participants will complete validated quality-of-life and clinical questionnaires remotely through the institutional digital platform (MiAsturSalud/SESPA). The study examines adherence, usability, caregiver support needs, changes in quality of life, and variations in healthcare resource utilization after digitalization of the assessment process.

Conditions

  • Leukemia Acute Myeloid
  • Leukemia Acute Lymphoid Leukemia (ALL)

Interventions

OTHER

Digital Structured Assessment Implementation

Integration of a structured set of validated clinical and patient-reported outcome questionnaires into the MiAsturSalud/SESPA digital platform for remote completion by older adults with acute leukemia. After a brief baseline visit, patients receive instructions and complete the EORTC QLQ-C30, FACT-Leu, and related measures at home within 48-72 hours, with a second digital assessment at 3-6 months. The system automatically records adherence, completion time, and caregiver support needs. All data are incorporated into routine clinical workflows. DSAI does not modify treatment or include automated alerts; its purpose is to evaluate feasibility, usability, and preliminary clinical impact of digitalizing structured assessments in real-world hematology practice.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Fundación para la Investigación Biosanitaria del Principado de Asturias

    lead OTHER

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-05-01
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07597590 on ClinicalTrials.gov