Developing a tool to monitor infections and quality of life in patients with blood cancers and immune issues
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
This study is testing a new tool that helps people with blood cancers like CLL or multiple myeloma report infections and track their quality of life to see how it can improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University Innsbruck Academic / other |
| Locations | 5 sites (Innsbruck, Tyrolia and 4 other locations) |
| Trial ID | NCT06821880 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a patient-reported outcome (PRO) tool to effectively identify infections in adults with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who have secondary immunodeficiency (SID). Participants will complete daily electronic questionnaires to report infection-related symptoms and health-related quality of life assessments every 1.5 months. The study will also evaluate the tool's diagnostic accuracy and its impact on treatment decisions, such as the initiation of immunoglobulin replacement therapy. Conducted across multiple centers in Germany and Austria, the study seeks to enroll 120 patients to gather comprehensive data over the treatment trajectory.
Who should consider this trial
Good fit: Ideal candidates include adult German-speaking patients aged 18 and older diagnosed with chronic lymphocytic leukemia or multiple myeloma and experiencing secondary immunodeficiency.
Not a fit: Patients who do not speak German or those without access to an internet device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance infection detection and improve the quality of life for patients with blood cancers and secondary immunodeficiency.
How similar studies have performed: While similar approaches have been explored, this specific PRO tool development for infection detection in hematological patients with SID is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Innsbruck, Tyrolia and 4 other locations
- Medizinische Universität Innsbruck — Innsbruck, Tyrolia, Austria (Recruiting)
- Medizinische Universität Graz — Graz, Austria (Not_yet_recruiting)
- BKH Kufstein — Kufstein, Austria (Not_yet_recruiting)
- Onkologischer Schwerpunkt am Oskar-Helene-Heim — Berlin, Germany (Not_yet_recruiting)
- Klinikum Garmisch-Partenkirchen — Garmisch-Partenkirchen, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Jens Lehmann, Ph.D.
- Email: jens.lehmann@i-med.ac.at
- Phone: +43 50 504 81551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.