Creating a Patient-Reported Tool to Detect Infections and Track Quality of Life in Adults with Blood Cancers and Secondary Immunodeficiency

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.

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