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

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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
Other Locations
Austria
Medizinische Universität Graz
NOT_YET_RECRUITING
Graz
Medizinische Universität Innsbruck
RECRUITING
Innsbruck
BKH Kufstein
NOT_YET_RECRUITING
Kufstein
Germany
Onkologischer Schwerpunkt am Oskar-Helene-Heim
NOT_YET_RECRUITING
Berlin
Klinikum Garmisch-Partenkirchen
NOT_YET_RECRUITING
Garmisch-partenkirchen
Contact Information
Primary
Jens Lehmann, Ph.D.
jens.lehmann@i-med.ac.at
+43 50 504 81551
Backup
Jan-Paul Bohn, Dr.
jan-paul.bohn@i-med.ac.at
+43 50 504 82916
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-07
Participants
Target number of participants: 120
Treatments
Patients with MM or CLL at risk of infectious complications due to SID
Sponsors
Leads: Medical University Innsbruck

This content was sourced from clinicaltrials.gov