Actively Recruiting
Developing a Patient-Reported Outcome Screening Tool for Infections and Measuring Quality of Life in Adults with Secondary Immunodeficiency Due to Chronic Lymphocytic Leukemia or Multiple Myeloma
Led by Medical University Innsbruck · Updated on 2025-02-12
120
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new patient-reported outcome (PRO) tool designed to detect infections in adults with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who have secondary immunodeficiency (SID). The study aims to improve infection detection and track changes in quality of life over time in this vulnerable group. This observational study is conducted at multiple centers in Germany and Austria and involves patients starting anticancer therapy. Participants will use a mobile app daily to complete electronic PRO questionnaires about infection-related symptoms. Quality of life questionnaires are completed every 1.5 months. Study visits occur every three months to document clinical data such as treatment updates, disease status, and infection history. The app was developed based on a tested software platform and includes features like push reminders to encourage daily symptom reporting. During the year-long participation, researchers will monitor the accuracy of the PRO tool in detecting infections, evaluate adherence to daily reporting, and assess quality of life using validated instruments. Clinical data will be collected and infections documented during quarterly visits. Patient safety and confidentiality are maintained according to ethical standards throughout the study.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (18 years of age or older)
- Access to an internet device such as a computer, tablet, or smartphone
- Able to communicate in German
- Diagnosed with multiple myeloma or chronic lymphocytic leukemia
- Have secondary immunodeficiency defined by recurrent infections, infections requiring inpatient treatment, or specific blood cell deficits
You will not qualify if you...
- None specified in the provided eligibility criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - Up to 1 year (365 days)
Participants complete daily electronic patient-reported outcome (ePRO) symptom assessments via a mobile app to monitor infection-related symptoms. Clinicians document infections and relevant clinical data during quarterly study visits.
Daily symptom reporting via app and visits every 3 months
Trial Site Locations
Total: 5 locations
1
Medizinische Universität Innsbruck
Innsbruck, Tyrolia, Austria, 6020
Actively Recruiting
2
Medizinische Universität Graz
Graz, Austria, 8010
Not Yet Recruiting
3
BKH Kufstein
Kufstein, Austria, 6330
Not Yet Recruiting
4
Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany, 14195
Not Yet Recruiting
5
Klinikum Garmisch-Partenkirchen
Garmisch-Partenkirchen, Germany, 82467
Not Yet Recruiting
Research Team
J
Jens Lehmann, Ph.D.
J
Jan-Paul Bohn, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here