NCT07597590Not yet recruiting
Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
Feasibility of a Structured Digital Patient-Reported Assessment Pathway in Older Adults With Acute Leukemia: A Prospective Single-Center Pilot Study
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 May 2026
- Start date
- Dec 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Fundación para la Investigación Biosanitaria del Principado de Asturias
- NCT number
- NCT07597590
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Dec 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Persistent inability to access or use the MiAsturSalud/SESPA platform despite reasonable technical support.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Central de Asturias (HUCA) Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.