Digital Patient-Reported Assessment in Older Adults With Acute Leukemia (NCT07597590) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Digital Patient-Reported Assessment in Older Adults With Acute Leukemia
Spain20 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Digital Implementation
Timeframe: Within 7 days after baseline.
Trial details
NCT IDNCT07597590
SponsorFundación para la Investigación Biosanitaria del Principado de Asturias