The problem of increased susceptibility to infections due to the weakened immune system caused by cancer therapy, can potentially be reduced by early detection of inflammatory processes. In the interventional feasibility study of the Clinic and Polyclinic for Gynecology of the Technical University of Munich, various data of patients undergoing systemic therapy due to breast or ovarian cancer will therefore be collected over a time frame of three months (between September 2021 and the end of August 2022).
The aim is to find out to what extent the vital parameters measured are suitable for telemonitoring, in particular for the early detection of infections and if these can even be treated remotely (remote patient care) – an aspect that was particularly important at the beginning and in the phases with high case numbers in the Corona pandemic.
This is a feasibility analysis. The primary endpoints are compliance (defined by wearing time of the in-ear sensor) and technical robustness of the PPG signal.
In addition, secondary endpoints of the measurements include number of true and false positive alarms (comparison of alarms to clinical data), number of contacts and hospitalization rates (comparison of alarms and resulting contacts and hospitalization rates to clinical data), infections (detection of infections from suspicious PPG signal transmissions or PROM data; resulting in a blood test to verify acute infections), impact on quality of life, and health-related costs (cost-effectiveness analysis).
The 100 adult study participants mainly suffer from breast or ovarian cancer and undergo various systemic therapies (e.g. chemotherapy, antibody therapy).
Two types of data collection serve as intervention. Firstly, questionnaires (PROM = Patient Reported Outcome Monitoring) are used, which can be completed by the participants via the app „Meine Busenfreundin“ developed by a team led by Professor Marion Kiechle of the Women’s Clinic at Klinikum rechts der Isar. This is linked to the clinic information system via data integration software, so that the data can be imported directly and evaluated by the study participants.
App “Meine Busenfreundin” – sample representation of the app screens (Source: play.google.com/store/apps/)
Secondly, cosinuss° in-ear sensors are used to record the vital parameters (cosinuss° Two). These are worn by the patients for a period of three months during the day and also for several hours at night. Using PPG and temperature sensors, pulse rate, oxygen saturation, body temperature and respiratory rate are measured continuously and sent to the cosinuss° Health platform via a stationary gateway. The collected data can be directly analyzed by the study participants via the cosinuss° Health web interface. At the same time, the platform is also linked to the hospital information system so that all collected data can also be imported and stored centrally.
In-ear sensor cosinuss °Two
Results and outlook
With 100 patients participating, recruitment is complete. The study will run until the end of September 2022.
The data will then be analyzed. The resulting scientific work will follow in the coming months. Corresponding results will be linked here as soon as the evaluations have been completed.