Feasibility of Monitoring Patients Who Have Cancer With a Smart T-shirt: Protocol for the OncoSmartShirt Study

Abstract

Background Studies have shown that there may be dissimilar perceptions on symptoms or side effects between patients with cancer and health care professionals. This may lead to symptomatic patients notifying the clinic irregularly or not telling the clinic at all. Wearables could help identify symptoms earlier. Patients with low socioeconomic status and less self-awareness of their health may benefit from this. A new design of wearables is a smart t-shirt that, with embedded sensors, provides measurement flows such as electrocardiogram, thoracic and abdominal respiration, and temperature. Objective This study evaluates the feasibility of using a smart t-shirt for home monitoring of biometric sensor data in adolescent and young adult and elderly patients during cancer treatment. Methods The OncoSmartShirt study is an explorative study investigating the feasibility of using the Chronolife smart t-shirt during cancer treatment. This smart t-shirt is designed with multiple fully embedded sensors and electrodes that engender 6 different measurement flows continuously. A total of 20 Danish patients with cancer ≥18 years old in antineoplastic treatment at Department of Oncology Rigshospitalet Denmark will be recruited from all cancer wards, whether patients are in curative or palliative care. Of these 20 patients, 10 (50%) will be <39 years old, defined as adolescent and young adult, and 10 (50%) will be patients >65 years old, defined as elderly. Consenting patients will be asked to wear a smart t-shirt daily for 2 weeks during their treatment course. Results The primary outcome is to determine if it is feasible to wear a smart t-shirt throughout the day (preferably 8 hours per day) for 2 weeks. Inclusion of patients started in March 2022. Conclusions The study will assess the feasibility of using the Chronolife smart t-shirt for home monitoring of vital parameters in patients with cancer during their treatment and bring new insights into how wearables and biometric data can be used as part of symptom or side-effect recognition in patients with cancer during treatment, with the aim to increase patients’ quality of life. Trial Registration ClinicalTrials.gov NCT05235594; https://beta.clinicaltrials.gov/study/NCT05235594 International Registered Report Identifier (IRRID) PRR1-10.2196/37626

Monitoring Adolescent and Young Adult Patients With Cancer via a Smart T-Shirt: Prospective, Single-Cohort, Mixed Methods Feasibility Study (OncoSmartShirt Study)

“…Further details on the OncoSmartShirt study can be reviewed in the previously published protocol article [36]. This paper reports results from 10 patients with cancer aged under 39 years (defined as AYAs).…”

“…This paper reports results from 10 patients with cancer aged under 39 years (defined as AYAs). The decision to have a sample size of 10 AYA patients was influenced by the feasibility study design, which does not require a formal power calculation but aligns with the sample sizes used for similar studies in the literature [36]. In the previously published protocol, the plan was to also include 10 patients with cancer older than 65 years (defined as elderly).…”

“…A semistructured interview guide was used. The interview guide was developed by SH based on research in the field [38,39] and consisted of questions about the pros and cons of using the smart T-shirt, material and appearance, identity and social stigma, behavioral changes, and ethics [36]. The interviews were performed by SH, who did not have prior knowledge about the participants and vice visa.…”

“…The OncoSmartShirt study was a feasibility study that tested a smart T-shirt for the home monitoring of AYA patients with cancer from a public health care hospital in Denmark. To investigate adherence, we had predefined a preferred wear time of 8 hours daily for 2 weeks [36]. Unfortunately, none of the included patients achieved this.…”

Research involvement and engagement of adolescent and young adults in a cancer trajectory: a 5-year experience from a patient support facility at a university hospital

“…In our real-life experience of PPI an example hereof was a research project including a wearable device for monitoring vital signs. Only by the input from patients in the phase of designing the research protocol was it possible to design a wearable study, which was feasible for AYAs according to wear time [ 34 ]. Our AYA population also described how patients both experience involvement processes [ 21 ] and how they see the impact of service user involvement from their perspective [ 25 ].…”