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Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

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

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Digital Patient-Reported Assessment Pathway

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.

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
2026-12-31
Primary Completion
2027-12-31
Completion
2028-06-30

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