In our research on patient involvement and engagement, we continuously came across the wish of health care users to be more at home during therapy. This also accounts for cancer patients receiving treatment within oncology. However, studies have shown that dissimilar perception on symptoms exist between cancer patients and health care professionals. eHealth technology might be able to solve this problem, so also patients with less awareness of own health can be more at home. A new design of a wearable is a smart t-shirt, this device has sensors embedded measuring e.g. electrocardiogram, thoracic and abdominal respiration, and temperature. A smart t-shirt might make it possible to monitor vulnerable oncology patient remotely on critical physical functions while at home. We therefore decided to design a study to investigate the feasibility of using a smart t-shirt for remote monitoring of biometric sensor data in adolescents and young adult (AYA, here defined as 18-39 years) patients during cancer treatment.

The design of the study was taken on in co-creation with an AYA oncology panel, consisting og AYAs in active cancer treatment or survivors after such.

The panel was informed about our research idea and introduced to the product: a smart t-shirt. The smart t-shirt was demonstrated, and it was possible to try it on and feel its fabric. The users were informed that the t-shirt had sensors and electrodes embedded, which if wanted could continuously measure 6 different measures. The researchers suggested a 6-week test period, where the users had to wear the t-shirt 12 hours each day. After thoroughly discussion with the user panel the research plan was adjusted, and researchers and user panel agreed on a 2-week test period with a daily wear-time of 8 hours. This adjustment was due to the fact that several patients have e.g. skin issues, implanted devices such as catheters, heat regulation issues etc. 

To perform the planned feasibility study of the smart t-shirt the study had to apply with regulations. Since the study site and the manufactures site were different issues were raised considering e.g. data processing agreement, GDPR, detailed legal matters and local regulations. After 18 months of negotiation with the authorities, the manufacturer etc. agreement was reach on all legal matters concerning a protocol for the feasibility of monitoring cancer patients with a smart t-shirt and the study will now enroll patients from February 2022.

10 AYAs undergoing oncological treatment will wear the t-shirt for 2 weeks preferably 8 hours per day. 

The primary endpoint is to assess the feasibility of using the smart t-shirt based on the completion rate. Secondary endpoints are to assess technical feasibility including data acquisition rate and data completeness. Also, qualitative interviews with the patients will be performed and a questionnaire on patient experience will be addressed.