Actively Recruiting
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
Led by Medical University Innsbruck · Updated on 2025-02-12
120
Participants Needed
5
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (≥18 years of age)
- Access to an internet device (e.g., personal computer, tablet, or smartphone with iOS or Android)
- German-speaking
- Diagnosis of multiple myeloma or chronic lymphocytic leukemia
- Secondary immunodeficiency defined by recurrent infections, infections needing inpatient treatment, low immunoglobulin levels, neutropenia, lymphopenia, or lymphocyte deficits assessed by flow cytometry
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Medizinische Universität Innsbruck
Innsbruck, Tyrolia, Austria, 6020
Actively Recruiting
2
Medizinische Universität Graz
Graz, Austria, 8010
Not Yet Recruiting
3
BKH Kufstein
Kufstein, Austria, 6330
Not Yet Recruiting
4
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany, 14195
Not Yet Recruiting
5
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany, 82467
Not Yet Recruiting
Research Team
J
Jens Lehmann, Ph.D.
CONTACT
J
Jan-Paul Bohn, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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