The aim of this observational study is to develop an ePRO symptom monitoring tool to
identify infections among patients with MM or CLL who recently started an anticancer
therapy.
This multicenter trial, conducted in participating sites in Germany in Austria, targets a
total of 120 adult patients to complete daily ePRO questions in a mobile app regarding
current infection-related symptoms.
Objectives:
Primary:
To develop and evaluate the diagnostic accuracy of a newly developed PRO screening
measure for detecting clinically diagnosed infections in hematological patients with SID.
Secondary:
To measure QoL over time using validated instruments such as the EORTC QLQ-C30 and
disease-specific modules (QLQ-MY20 for MM and QLQ-CLL17 for CLL).
Explore whether PRO-based infection detection prompts subsequent initiation of
immunoglobulin replacement therapy (IgRT) and examine QoL before and after its
initiation.
Exploratory Objectives:
To develop a reliable item list to monitor and detect infections, it is necessary to
establish a high-quality measurement of infections as criterion. We developed the item
list based on items from the European Organisation for Research and Treatment of Cancer
(EORTC) Item Library and in line with international best-practice recommendations for
item list development. The development comprised a comprehensive review of the literature
and existing measures measuring infection-related symptoms, as well as physician input on
which domains and symptoms were the most relevant to assess to monitor for infections in
this population.
Clinicians will also document any diagnosed infections and relevant clinical data
throughout study visits, which take place every three months. These include updates on
treatment regimens, disease staging, and infection history.
The app was developed based on the Computer-based Health Evaluation System (CHES)
software platform, which allowed for real-time symptom tracking and data integration. The
software has been used extensively and also been tested with patients with hematological
diseases in the past. For the PRO-SID app, we developed study-specific content, which
comprised information in lay language on the diseases (MM and CLL), information on
infections and SID, and information on the study itself. The native app (iOS and Android)
prompts patients to complete the item list once daily via push-reminders (up to two
reminders).
Usability of the app and understanding of the item list within the daily ePRO assessment
on infection symptoms has been assessed within a designed feasibility study according to
best practice guidelines (data to be published separately). After completion of the
feasibility study, we implemented changes to the app based on patients' feedback and
answers in the evaluation questionnaires in order to improve the app for the final study.
Patient Safety and Ethics:
The study is conducted in compliance with the Declaration of Helsinki and Good Clinical
Practice standards. Informed consent is obtained, and all participant data is
de-identified and securely stored to ensure confidentiality.