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
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
None
The study population are subjects with MM or CLL and a SID who have recently started a anticancer therapy in Germany and Austria.
Cohort
Prospective
Not listed
Diagnostic accuracy of the ePRO monitoring instrument for infection-related symptoms
Evaluation of diagnostic accuracy of the daily ePRO screening measure to detect infections as diagnosed by a clinician (CTCAE).
Changes in health-related quality of life measured with the EORTC QLQ-C30
Changes in health-related quality of life over the study period (from inclusion to six and 12 months) measured with the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30).
Changes in health-related quality of life measured with the EORTC QLQ-MY20
Changes in health-related quality of life over the study period (from inclusion to six and 12 months) measured with the EORTC disease-specific module QLQ-MY20 - a 20 item instrument designed to assess the quality of life of patients with multiple myeloma.
2. Changes in health-related quality of life measured with the EORTC QLQ-CLL17
Description: Changes in health-related quality of life over the study period (from inclusion to six and 12 months) measured with the EORTC disease-specific module QLQ-CLL17 - a 17 item instrument designed to assess the quality of life of patients with chronic lymphocytic leukemia.
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