A study to evaluate the use of a smartphone application and biosensor by cancer participants undergoing systemic treatments.

Who can participate?  
People aged between 18 to 80 years with a confirmed diagnosis of solid tumours.   

What does the study involve?
Participants may be asked to be in the study for a maximum of 12 months. This includes: 

• Initial Survey: The participant will be asked to fill up a 10-min basic survey regarding demographics (education, marital status, income, etc.), health information and technology ownership and technology use for health purposes  
• Observation Phase: Participants will be provided with a pre-paired Samsung Galaxy Watch3 and a Samsung Galaxy A12 smartphone with the pre-installed Project Zebra app. The participant will be asked to wear a Samsung Galaxy Watch3 biosensor device, which will automatically measure the vital signs (heart rate, oxygen level in blood, activity, sleep and falls), and to complete daily surveys regarding the symptoms and any unplanned visits to the hospital or emergency department, daily, for a 2-week or 6-week period  
• Interview or Focus Group:  After completion of the Observation Phase, some participants may be asked to participate in an interview or focus group via phone or video conferencing. If selected, they will be asked questions about the experience with the sensor and the app  
• At the end of the study period, participants will be asked to return the Samsung Galaxy Watch3 biosensor and Samsung Galaxy A12 smartphone to the care team and complete a qualitative survey  

Participants will be recruited in one of the following Phase:  

• Vanguard Phase:  The participants will be asked to wear the Sensor and use the APP 24-hours, daily for a period of 2 weeks  
• Operational Phase: If the Vanguard Phase is completed, the participants will be recruited in this phase and will be asked to wear the Sensor and use the APP 24-hours, daily for up to 6 weeks.  

What are the possible benefits and risks of participating?
Participants will not receive any direct medical benefit from participating in this study, but the information will help researchers and doctors to learn more about improving side effect management and reducing unnecessary trips to the emergency department and hospital. Also, they will receive a total of $115 in two-parts for their participation in the study.  

There are no major risks from participating in the study, but participants may experience the following:  

• Wearing the Samsung Galaxy Watch3 may cause skin irritation and discomfort  
• A small risk of becoming distressed from reflecting on the symptom and emergency department and hospital visits while completing the in-app questionnaire and study surveys  
• Although the sponsor takes great care to protect participant’s information, there is a slight risk of loss of confidentiality. 
• There are potential safety risks associated with the use of the Samsung Galaxy Watch3 which include inhalation or swallowing of small parts can be dangerous or even fatal, burns and explosions if batteries are exposed to fire, etc. 
• There are potential safety risks associated with the use of the Samsung Galaxy A12 smartphone which include electric shocks, if the device is wet or used with wet hands while charging, prolonged use might increase the device temperature 

Where is the study run from?
Genentech (USA)

When is the study starting and how long is it expected to run for?
December 2020 to October 2023

Who is funding the study?
F. Hoffmann-La Roche (USA)

Who is the main contact?
Dr Elaine Yu, [email protected]