Study: overview and objective
The pilot study will examine how well the smartphone application bwHealthApp and the sensors used can be integrated into patients’ everyday lives, how reliable the data are, and whether this technology can be used to make cancer therapy in the day clinic at Tübingen University Hospital better, more individualized, and more effective in the future.
“In the future, we want to enable personalized cancer therapy that can be integrated into patients’ everyday lives with the help of modern wearables.”
In the long term, the app used is intended to be an important component of personalized medicine by linking various sensors, wearables and medical devices with each other and recording and analyzing their data. In addition to the cosinuss° in-ear sensors and fitness wristbands, this also includes implantable devices.
The study started at the end of July 2022 and will run for a total of about four months.
The study participants will come to the oncology day clinic of the University Hospital Tübingen every few weeks for systemic cancer therapy. This is where the initial setup and instruction of the app and wearables takes place. The participants are not given any instructions on how often and during which activities they have to wear the sensor. The manual entries in the app are also based on a voluntary basis.
Over a period of about one month, the participants use the in-ear sensor or the wristband in their daily lives. Among other things, heart rate, body temperature and oxygen saturation (SpO2) are measured and recorded.
In addition, the participants enter information into the bwHealthApp. Besides the current quality of life, certain events can also be entered here, such as sporting activity or side effects of the therapy.
At the end of the four-week period, participants complete a feedback questionnaire on the study, the app and the device used.
Pictures: Alfred Siewe-Reinke, Hochschule Reutlingen, 2022
Approximately 30 cancer patients (m/f/d) undergoing systemic therapy (chemotherapy, immunotherapy) are participating in the study.
By lottery, one part of the group will receive a fitness tracker wristband and another part will receive the cosinuss° in-ear sensor °Two for automated recording of vital parameters.
On the one hand, data is automatically recorded by means of the sensors. This includes, depending on the device used, the following:
- Heart rate
- Body temperature
- Oxygen saturation
- Calories burned
- Number of steps
- Activity duration
- Sleep duration
On the other hand, participants make manual entries in the app. These include activities and events as well as answers to questionnaires, such as the EORTC QLQ-C30 questionnaire. This questionnaire, which is integrated into the app, is based on the “EORTC Quality of Life”. It has been translated and validated in over 100 languages and is used in more than 5,000 studies worldwide every year (https://qol.eortc.org/).
The sensor’s measurement data is sent to the smartphone app via Bluetooth Low Energy (BLE). From there, the data is sent via a secure Internet connection (TLS encryption via WLAN) to the server of the computer center at Reutlingen University. If there is no Internet connection, the data is temporarily stored on the smartphone. A specially developed web platform visualizes the collected data so that it can be monitored and analyzed by medical staff.
“Among other things, the cosinuss° sensors convinced us as a convenient alternative to fitness wristbands due to the measurement in the ear.”
The cosinuss° sensors were chosen, among other things, because of the possibility of measuring vital parameters in the ear, which represents a comfortable alternative to a wristband for many study participants. Furthermore, in addition to pulse rate, the cosinuss° Two offers two additional relevant vital signs: Oxygen saturation (SpO2) and body temperature. Another decision criterion was the possibility of energy-saving data transmission between sensor and smartphone via Bluetooth Low Energy.
cosinuss° in-ear sensor °Two
For more information on the data security of the technical setup, click here: https://bwhealthapp.reutlingen-university.de/page/home/#dataEncryption
Results and outlook
The study started at the end of July 2022. Initial results are therefore not yet available. These will be published here as soon as the data have been collected and analyzed.