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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 weakened immune system (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) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

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