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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
Sponsor: Medical University Innsbruck
Summary
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 clinical data
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2025-02-03
Completion Date
2026-07
Last Updated
2025-02-12
Healthy Volunteers
No
Locations (5)
Medizinische Universität Innsbruck
Innsbruck, Tyrolia, Austria
Medizinische Universität Graz
Graz, Austria
BKH Kufstein
Kufstein, Austria
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany