This is an observational study to investigate if it is feasible to recruit 100 patients receiving radiotherapy (RT) to metastatic disease to wear Hexoskin and if Hexoskin will facilitate the monitoring, detection and early treatment of RT-related side effects.
Radiotherapy is an important adjunct in the interdisciplinary care of the palliative patient population, providing the potential for improved quality of life and symptom control, often translating into improved well-being, function and mobility. Changes in pain and QOL are frequently measured subjectively using patient-reported questionnaires. Objective measures such as respiratory rate, pulse rate, activity level and sleep duration and quality, may complement the currently available tools. Such tools may lead to better evaluation of the effects of palliative RT with real-time detection of potential complications and toxicity and the acute need for analgesic adjustments that can result from successful palliative RT.
Study Type
OBSERVATIONAL
Enrollment
100
Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
RECRUITINGRate of patient accrual
Feasibility of accruing 100 patients to the study
Time frame: Over 12 months
Frequency of radiotherapy related adverse events
Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring.
Time frame: Baseline to 12 months
Quality Adjusted Life Years (QALY)
Perform economic and health technology assessment using EuroQol-5 Dimension-5 Level (EQ-5D-5L) health questionnaire. (100 is the best health a patient can imagine while 0 is the worst health a patient can imgaine.)
Time frame: Baseline to 12 months
Health Related Quality of Life (QOL)
Perform Health Related Quality of Life using EORTC QLQ-C30 and rate electronic survey completion.
Time frame: Baseline to 12 months
Number of Trial Refusals
Evaluate reasons for trial refusal
Time frame: Baseline to 12 months
Complete follow-ups
Rate of completed follow-ups
Time frame: Baseline to 12 months
Patient experience and satisfaction
Measure patient experience and satisfaction using mobile app (Zamplo) and Hexoskin
Time frame: Baseline to 12 months
Patient Adherence
Patient adherence to using the Hexoskin Medical System
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Time frame: Baseline to 12 months
Hexoskin data collection rates
Feasibility of data collection using the Hexoskin Medical System
Time frame: Baseline to 12 months
Quality of Life (QOL) survey completion
Rate of Quality of Life (QOL) survey completion on mobile app (Zamplo)
Time frame: Baseline to 12 months
Overall survival of participants
Overall survival time is calculated from study enrollment to date of death or last follow-up
Time frame: Baseline to 12 months
Characterize adverse event profile
Characterize adverse event profile of various radiotherapy regimens given for metastases
Time frame: Baseline to 12 months