Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 7 months later May 1, 2027 → Dec 2027
See other at-risk trials from Fundación para la Investigación Biosanitaria del Principado de Asturias

Record History

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  1. Study completion moved earlier from Jun 2028 to Mar 2028 Show 5 more changesShow less
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 510 words
    • Site contact updated
    • Publications: details revised at 5 of 5 entries
  2. Primary completion pushed from May 1, 2027 to Dec 2027v2 Show 7 more changesShow less
    • Start date: Mar 1, 2026 to Dec 2026
    • Trial status changed: Active, Not Recruiting → Not Yet Recruiting
    • Study completion moved earlier from Dec 31, 2028 to Jun 2028
    • Interventions: Digital Structured Assessment Implementation (Other) to Digital Patient-Reported Assessment Pathway (Other)
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints revised (3)
    • Study title shortened, about 2 words
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07597590
Lead Sponsor Fundación para la Investigación Biosanitaria del Principado de Asturias
Collaborators: Otsuka Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Related terms Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov