RecruitingNCT06821880

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

Enrollment

120 participants

Start Date

Feb 3, 2025

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study develops a new patient-reported questionnaire to track infection symptoms and quality of life in people with blood cancers (multiple myeloma or chronic lymphocytic leukemia) who have weakened immune systems. Participants will report their symptoms through an app over time. **You may be eligible if...** - You are 18 or older - You speak German - You have been diagnosed with multiple myeloma or chronic lymphocytic leukemia (CLL) - You have signs of weakened immunity (such as frequent infections, low antibody levels, or low white blood cell counts) - You have access to a smartphone, tablet, or computer with internet **You may NOT be eligible if...** - You do not speak German - You do not have reliable internet access or a compatible device - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06821880


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