Digital Patient-Reported Assessment in Older Adults With Acute Leukemia

Condition(s) studied

Investigational drug(s) / intervention(s)

Digital Patient-Reported Assessment Pathway: 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.

Study 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 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.

Eligibility

Primary outcome measure(s)

• Feasibility of Digital Implementation — Within 7 days after the baseline visit.
  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.

Trial sites (1)

More Fundación para la Investigación Biosanitaria del Principado de Asturias trials in Spain

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