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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Structure Assessment Pathway | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Structured Assessment Implementation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Digital Implementation | Proportion of participants completing ≥80% of the digital assessment battery after the baseline visit. | Within 7 days after baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Support Requirement | Proportion of participants requiring caregiver assistance to complete the digital battery. | Within 7 days after baseline. |
| Dropout Rate | Percentage of participants who discontinue digital follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Central de Asturias (HUCA) | Oviedo | Principality of Asturias | 33011 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38035561 | Background | 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. | |
| 39444707 | 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. |
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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.
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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.
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|
| From baseline to 3-6 months. |
| Time Required for Digital Completion | Mean time (minutes) required to complete the digital questionnaires. | Within 7 days after baseline. |
| 41646091 | 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. |
| 34521609 | 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. |
| 36857630 | 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. |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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