Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

NCT07597590 | Not Yet Recruiting

• 1 other identifier: 2025.519
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

acute leukemia; older adults; feasibility study; electronic patient-reported outcomes; digital health implementation

Outcome Measures

Primary Outcomes (1)

• Feasibility of Digital Implementation

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

  Within 7 days after baseline.

Secondary Outcomes (3)

• Caregiver Assistance Requirement

  Within 7 days after baseline.

• Non-completion of Planned Digital Follow-up Assessment

  From baseline to 3-6 months.

• Time Required for Digital Completion

  Within 7 days after baseline.

Study Arms (1)

Digital Patient-Reported Assessment Pathway

EXPERIMENTAL

Other: Digital Patient-Reported Assessment Pathway

Interventions

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.

Digital Patient-Reported Assessment Pathway

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

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: 38035561 BACKGROUND

• 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: 39444707 BACKGROUND

• 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: 41646091 BACKGROUND

• 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: 34521609 BACKGROUND

• 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: 36857630 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Maria Antuna-Casal, PhD

CONTACT

+34 661446805; antunamaria@uniovi.es

Maria Antuna

CONTACT

antunamaria@uniovi.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This is a prospective, longitudinal, single-group pilot feasibility study evaluating the digital implementation of a structured patient-reported assessment pathway. Recruitment will begin after activation of the institutional MiAsturSalud/SESPA platform, anticipated in December 2026. Adults aged ≥65 years with acute leukemia receiving ambulatory follow-up at Hospital Universitario Central de Asturias will be recruited consecutively. Participants will complete the EORTC QLQ-C30 and FACT-Leu remotely after the baseline visit and 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 include 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 and will not formally assess acceptability or usability.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the principal study results and ending 5 years thereafter.
• Access Criteria: Requests must include a methodologically sound research proposal and will be subject to approval by the principal investigators and relevant institutional governance bodies. Access will require an appropriate data-use agreement and compliance with applicable ethics and data-protection requirements

Locations

ES (1)