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

Recruiting now

Conditions studied: Chronic Lymphocytic Leukaemia (CLL), Multiple Myeloma (MM), Secondary Immunodeficiency (SID)

In brief

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 facts

Study ID

NCT06821880

Run by

Medical University Innsbruck

People needed

120

Starts

2025-02-03

Expected to finish

2026-07-01

Last updated by the study team

2025-02-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• Medizinische Universität Innsbruck — Innsbruck, Tyrolia, Austria (enrolling)
• Medizinische Universität Graz — Graz, Austria
• BKH Kufstein — Kufstein, Austria
• Onkologischer Schwerpunkt am Oskar-Helene-Heim — Berlin, Germany
• Klinikum Garmisch-Partenkirchen — Garmisch-Partenkirchen, Germany

Full record on ClinicalTrials.gov

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