NCT07597590

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
32mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2028

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Leukemia Acute MyeloidLeukemia Acute Lymphoid Leukemia (ALL)

Keywords

acute leukemiaolder adultsdigital health implementationspatient-reported outcomesfeasibility studygeriatric assessment

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Digital Implementation

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

    Within 7 days after baseline.

Secondary Outcomes (3)

  • Caregiver Support Requirement

    Within 7 days after baseline.

  • Dropout Rate

    From baseline to 3-6 months.

  • Time Required for Digital Completion

    Within 7 days after baseline.

Study Arms (1)

Digital Structure Assessment Pathway

EXPERIMENTAL
Other: Digital Structured Assessment Implementation

Interventions

Digital Structured Assessment ImplementationOTHER

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.

Digital Structure Assessment Pathway

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (5)

  • Woods JD, Klepin HD. Geriatric Assessment in Acute Myeloid Leukemia. Acta Haematol. 2024;147(2):219-228. doi: 10.1159/000535500. Epub 2023 Nov 30.

    PMID: 38035561BACKGROUND

  • Franzoi MA, Ferreira AR, Lemaire A, Rodriguez J, Grosjean J, Ribeiro JM, Polastro L, Grellety T, Artignan X, Le Du K, Pagliuca M, Nouhaud E, Autheman M, Andre F, Basch E, Metzger O, Ferte C, Di Palma M, Scotte F, Vaz-Luis I. Implementation of a remote symptom monitoring pathway in oncology care: analysis of real-world experience across 33 cancer centres in France and Belgium. Lancet Reg Health Eur. 2024 Jul 31;44:101005. doi: 10.1016/j.lanepe.2024.101005. eCollection 2024 Sep.

    PMID: 39444707BACKGROUND

  • Aanes SG, Wiig S, Nieder C, Haukland EC. Implementing digital patient-reported outcomes in routine cancer care: barriers and facilitators. ESMO Real World Data Digit Oncol. 2024 Oct 23;6:100088. doi: 10.1016/j.esmorw.2024.100088. eCollection 2024 Dec.

    PMID: 41646091BACKGROUND

  • Peipert JD, Efficace F, Pierson R, Loefgren C, Cella D, He J. Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia. J Geriatr Oncol. 2022 Sep;13(7):935-939. doi: 10.1016/j.jgo.2021.09.007. Epub 2021 Sep 11.

    PMID: 34521609BACKGROUND

  • Basch E, Rocque G, Mody G, Mullangi S, Patt D. Tenets for Implementing Electronic Patient-Reported Outcomes for Remote Symptom Monitoring During Cancer Treatment. JCO Clin Cancer Inform. 2023 Feb;7:e2200187. doi: 10.1200/CCI.22.00187.

    PMID: 36857630BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: This study is a prospective, longitudinal, single-arm pilot feasibility and implementation study with a pre-post within-person component designed to evaluate the feasibility of transferring structured assessment from outpatient consultation to a digital environment under routine clinical conditions. Given its pilot nature and small sample size, the study focuses on estimating feasibility, acceptability and usability, and on generating preliminary within-person outcome signals rather than establishing confirmatory clinical efficacy. The study will be conducted in the Haematology Service of Hospital Universitario Central de Asturias (HUCA), a tertiary public hospital in Asturias, Spain. The digital component will be implemented through the monitoring platform of the regional public health service (SESPA), integrated into the patient-facing digital environment MiAsturSalud. Recruitment will be based on consecutive sampling of eligible patients during the planned study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data collected in this study will not be made publicly available due to the small sample size and the potential risk of participant identification. De-identified data underlying the results reported in future publications may be made available from the corresponding author upon reasonable request, subject to approval by the institutional ethics committee and in accordance with applicable data protection regulations.

Locations

ES(1)