Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study
Sponsor study identifier
interventional
20
1 country
1
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2026
Actual (reported)May 19, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Feasibility of Digital Implementation
Percentage of all enrolled participants who answer at least 80% of the 74 items in the baseline digital questionnaire battery comprising the EORTC QLQ-C30 and FACT-Leu within 7 days after the baseline visit. Meeting this criterion requires at least 60 answered items. The numerator will include participants meeting this criterion, and the denominator will include all enrolled participants. Responses saved within the assessment window will count irrespective of formal battery submission. Participants with fewer than 60 answered items, including those with no recorded responses, will not meet the criterion. Individual items may be skipped; the 74-item denominator does not imply mandatory responses. The percentage will be reported with a 95% confidence interval.
Within 7 days after the baseline visit.
Caregiver Assistance Requirement
Within 7 days after the baseline visit.
Non-completion of Planned Digital Follow-up Assessment
8-12 weeks after individual digital pathway activation.
Elapsed Time to Reach the Baseline Questionnaire Completion Threshold
Within 7 days after the baseline visit.
Following individual activation of the MiAsturSalud/SESPA digital pathway, participants will complete the EORTC QLQ-C30 and FACT-Leu remotely. The baseline assessment will be scheduled 48-72 hours after the baseline visit, with a primary outcome assessment window extending to 7 days after that visit. A second digital assessment will be scheduled 8-12 weeks after individual pathway activation. The platform will permit skipped items, save partial responses, and allow participants to resume the baseline assessment within the 7-day window. Questionnaire item responses and timing data will be recorded, and practical caregiver assistance will be documented. The questionnaire pathway will not generate automated clinical alerts or mandate treatment changes. Participants will not concurrently receive the broader project's home-monitoring and clinical-alert intervention during this feasibility study. Usual clinical care will continue.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario Central de Asturias (HUCA)
Oviedo, Principality of Asturias, 33011, Spain
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.
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.
First Submitted
May 13, 2026
First Posted
May 19, 2026
Contact the study team to confirm eligibility.
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.
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.
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.
Study Start
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 7, 2026
Record last verified: 2026-10
De-identified individual participant data underlying results reported in publications arising from this study, together with the corresponding data dictionary and statistical analysis code, will be available from the principal investigators upon reasonable request. Access will be subject to a methodologically sound proposal, institutional governance review, an appropriate data-use agreement and applicable ethics and data-protection requirements. Owing to the small sample size and risk of re-identification, participant-level data will not be deposited in an openly accessible public repository.
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Source: ClinicalTrials.gov.
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