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.
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.
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.
Single group
Digital Patient-Reported Assessment Pathway
Other interventionFollowing 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.
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.
Caregiver Assistance Requirement
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
Proportion of all enrolled participants who do not answer at least 60 of the 74 items in the EORTC QLQ-C30 and FACT-Leu follow-up digital questionnaire battery during the assessment window of 8-12 weeks after individual digital pathway activation. Completion will be determined from responses saved within this window, irrespective of formal battery submission. Participants with fewer than 60 answered items, including those with no recorded follow-up responses, will be classified as not completing the follow-up assessment. Reasons will be recorded where ascertainable, including voluntary withdrawal, technical difficulties, clinical deterioration, disease progression, hospitalization, death, and loss to follow-up, and reported separately.
Elapsed Time to Reach the Baseline Questionnaire Completion Threshold
Elapsed time, in minutes, between the first saved item response in the baseline digital questionnaire battery and the first time at which at least 60 distinct items out of 74 have saved responses. This measure will be calculated among participants who reach this threshold within 7 days after the baseline visit, using platform timestamps. Elapsed time will include pauses and intervals between sessions and will not be interpreted as active questionnaire completion time. Participants who do not reach the threshold will not be assigned a completion time; their number will be reported separately.
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Fundación para la Investigación Biosanitaria del Principado de Asturias
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborator
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