Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Patient-Reported Assessment Pathway.
- Who it may be relevant to
- Registry conditions: Leukemia Acute Myeloid, Leukemia Acute Lymphoid Leukemia (ALL). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study
Overview
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.
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 gener
Primary outcome measures
- Feasibility of Digital Implementation [Time frame: Within 7 days after baseline.]
Secondary outcome measures (3)
- Caregiver Assistance Requirement [Time frame: Within 7 days after baseline.]
- Non-completion of Planned Digital Follow-up Assessment [Time frame: From baseline to 3-6 months.]
- Time Required for Digital Completion [Time frame: Within 7 days after baseline.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Spain · 1 center
- Hospital Universitario Central de Asturias (HUCA) — Oviedo
Publications
- 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
- 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 PMID 39444707
- 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
- 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
- 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
Identifiers
NCT: NCT07597590 · 2025.519