Clinical trial · Interventional
Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia Acute Lymphoid Leukemia (ALL) | Acute Lymphoblastic Leukemia | ALIAS | 0.85 |
| Leukemia Acute Myeloid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Patient-Reported Assessment Pathway | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Digital Patient-Reported Assessment Pathway
- interventionNames
- Other: Digital Patient-Reported Assessment Pathway
Primary outcomes (1)
- measure
- Feasibility of Digital Implementation
- timeFrame
- Within 7 days after baseline.
- description
- Proportion of participants completing at least 80% of all required items across the EORTC QLQ-C30 and FACT-Leu baseline digital questionnaire battery.
Secondary outcomes (3)
- measure
- Caregiver Assistance Requirement
- timeFrame
- Within 7 days after baseline.
- description
- Proportion of participants requiring practical caregiver assistance to access or navigate the platform, read questionnaire content or enter responses selected by the participant. Independent proxy completion will not be permitted.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDWoods 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
- BACKGROUNDFranzoi 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
- BACKGROUNDAanes 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
- BACKGROUNDPeipert 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
- BACKGROUNDBasch 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