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NCT Number: NCT07597590

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.

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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 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.

Treatment and study plan

Digital Patient-Reported Assessment Pathway

Other

Following activation of the MiAsturSalud/SESPA digital pathway, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit. The baseline digital assessment will be scheduled within 48-72 hours, with an outcome assessment window extending to 7 days. A second digital assessment will be scheduled at 3-6 months. The platform will record questionnaire completion status and elapsed completion time, and caregiver assistance will be documented. The pathway will not generate automated clinical alerts or mandate changes to treatment.

Primary outcomes

  1. Feasibility of Digital Implementation

    Time frame: Within 7 days after baseline.

    Proportion of participants completing at least 80% of all required items across the EORTC QLQ-C30 and FACT-Leu baseline digital questionnaire battery.

Secondary outcomes

  1. Caregiver Assistance Requirement

    Time frame: Within 7 days after baseline.

    Proportion of participants requiring practical caregiver assistance to access or navigate the platform, read questionnaire content or enter responses selected by the participant. Independent proxy completion will not be permitted.

  2. Non-completion of Planned Digital Follow-up Assessment

    Time frame: From baseline to 3-6 months.

    Proportion of participants who do not complete the planned digital follow-up assessment at 3-6 months. Reasons for non-completion will be categorised where ascertainable, including voluntary withdrawal, technical difficulties, clinical deterioration, disease progression, hospitalisation, death and loss to follow-up.

  3. Time Required for Digital Completion

    Time frame: Within 7 days after baseline.

    Elapsed time, in minutes, required to complete the baseline digital questionnaires.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Antuna

CONTACT

[email protected]

Maria Antuna-Casal, PhD

CONTACT

[email protected]

+34 661446805

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

Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 19, 2026
Registry last updated
Aug 6, 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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