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Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project

Recruitingn/aAges 18 Years - anyAllMedical University Innsbruck
NCT06821880 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to improve the treatment of hematological patients with secondary immunodeficiency (SID) by developing a patient-reported outcome (PRO) instrument to detect clinically diagnosed infections. The study focuses on adults diagnosed with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who are at increased risk of infections due to SID. The main questions it aims to answer are: 1. Can a newly developed PRO screening tool for infection-related symptoms reliably detect infections in patients with SID? 2. How does the health-related quality of life change over the treatment course Participants will: * Complete daily electronic PRO questionnaires (ePRO) to monitor infection-related symptoms * Complete ePRO health-related quality of life questionnaires every 1.5 months * Participate in study visits every three months to ensure documentation of

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult patient (\>=18 years of age) * Access to an internet device (e.g., personal computer or tablet to use a web-based platform, or smartphone where the study app can be installed - all common iOS and Android systems) * German-speaking * Diagnosis of multiple myeloma or chronic lymphocytic leukemia * Secondary immunodeficiency (defined as: recurrent infections, infections requiring inpatient treatment, hypogammaglobulinemia, neutropenia and/or lymphopenia on differential blood cell counts, deficit in lymphocyte subsets as assessed by flow cytometry)
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What it tests

  • Not listed
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Where

5 sites
Medizinische Universität Innsbruck
Innsbruck, Austria
Medizinische Universität Graz
Graz, Austria
BKH Kufstein
Kufstein, Austria
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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