Leukemia Acute Lymphoid Leukemia (ALL), Leukemia Acute Myeloid
Conditions
Keywords
acute leukemia, older adults, feasibility study, electronic patient-reported outcomes, digital health implementation
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.
Interventions
OTHERDigital 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 generate automated clinical alerts or mandate changes to treatment.
Sponsors
Fundación para la Investigación Biosanitaria del Principado de Asturias
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Digital Implementation | Within 7 days after baseline. | Proportion of participants completing at least 80% of all required items across the EORTC QLQ-C30 and FACT-Leu baseline digital questionnaire battery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Assistance Requirement | Within 7 days after baseline. | 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. |
| Non-completion of Planned Digital Follow-up Assessment | From baseline to 3-6 months. | Proportion of participants who do not complete the planned digital follow-up assessment at 3-6 months. Reasons for non-completion will be categorised where ascertainable, including voluntary withdrawal, technical difficulties, clinical deterioration, disease progression, hospitalisation, death and loss to follow-up. |
| Time Required for Digital Completion | Within 7 days after baseline. | Elapsed time, in minutes, required to complete the baseline digital questionnaires. |
Countries
Spain
Contacts
CONTACTMaria Antuna-Casal, PhD
CONTACTMaria Antuna
Outcome results
None listed