Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

This study evaluates the implementation of a digital questionnaire pathway within the institutional MiAsturSalud/SESPA platform at Hospital Universitario Central de Asturias, Oviedo, Spain. It constitutes a defined feasibility component of the broader CEImPA 2025.519 project.

The baseline digital assessment will be scheduled 48-72 hours after the baseline visit. Responses saved within 7 days after that visit will contribute to the primary outcome. The follow-up digital assessment will take place during the window of 8-12 weeks after individual activation of the digital pathway.

The questionnaire battery comprises the 30-item EORTC QLQ-C30 and the 44-item FACT-Leu, giving a total of 74 items. The platform will permit individual items to be skipped, progressively save partial responses, and allow participants to resume an incomplete assessment within the corresponding assessment window. These functions and the timestamp recording required for outcome measurement will be implemented and verified before recruitment begins.

The primary outcome will be the proportion of all enrolled participants who answer at least 80% of the baseline battery items within 7 days after the baseline visit. Meeting this criterion requires at least 60 answered items out of 74. Outcome ascertainment will use responses saved by the end of the assessment window, irrespective of formal battery submission. All enrolled participants will be included in the denominator; those with fewer than 60 answered items, including those with no recorded responses, will not meet the criterion.

The same threshold of at least 60 answered items out of 74 will define completion of the follow-up assessment within the 8-12-week window. Follow-up completion status will be determined at the end of this window, irrespective of formal battery submission. Reasons for non-completion will be recorded where ascertainable and reported separately, distinguishing technical or participation-related barriers from clinical events preventing assessment.

Elapsed baseline completion time will be measured in minutes from the first saved item response to the first time at which at least 60 distinct items have saved responses. This measure will be calculated among participants who reach the threshold within the 7-day baseline window. It 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.

The item-completion criterion is an operational measure of implementation feasibility and is separate from the instrument-specific rules for calculating questionnaire scores. The 80% threshold is a pragmatic criterion and is not an externally validated benchmark or a stand-alone progression rule. The participant-level feasibility estimate and its 95% confidence interval will be interpreted alongside item-completion patterns, caregiver assistance, follow-up non-completion and its reasons, and elapsed time to the baseline completion threshold to identify modifications needed before a larger evaluation.

Throughout this component's baseline and follow-up period, participants will not concurrently receive the broader project's home-monitoring and clinical-alert intervention. The study questionnaire pathway will not generate automated clinical alerts or mandate treatment changes. Home monitoring and clinical-alert functions are planned for a subsequent phase and are outside the scope of this registered feasibility study. Usual clinical care will continue.