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NCT Number: NCT07597590

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Leukemia Acute Myeloid Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia Acute Lymphoid Leukemia (ALL) Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥65 years.
  • Confirmed diagnosis of acute leukemia.
  • Active ambulatory follow-up in the Hematology Service.
  • Ability to complete questionnaires independently or with caregiver support.
  • Access to a compatible digital device (patient or caregiver).
  • Signed informed consent.

Exclusion criteria

  • Severe cognitive impairment preventing participation (per clinical judgment and baseline screening).
  • Terminal clinical condition with limited life expectancy.
  • Non-resolvable technical impossibility of digital access.

Treatment and study plan

Digital Structured Assessment Implementation

Other

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.

Primary outcomes

  1. Feasibility of Digital Implementation

    Time frame: Within 7 days after baseline.

    Proportion of participants completing ≥80% of the digital assessment battery after the baseline visit.

Secondary outcomes

  1. Caregiver Support Requirement

    Time frame: Within 7 days after baseline.

    Proportion of participants requiring caregiver assistance to complete the digital battery.

  2. Dropout Rate

    Time frame: From baseline to 3-6 months.

    Percentage of participants who discontinue digital follow-up.

  3. Time Required for Digital Completion

    Time frame: Within 7 days after baseline.

    Mean time (minutes) required to complete the digital questionnaires.

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

Clinical Impact and Feasibility of the Digital Implementation of a Structured Assessment in Patients ≥65 Years With Acute Leukemia: A Prospective Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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