Patient Reported Outcomes/Metrics Program Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation

Conditions
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Metastatic Cancer, Palliative

Intervention / Treatment
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* Device: Hexoskin Medical System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned to receive palliative radiotherapy for pain Known cancer diagnosis Able to wear Hexoskin Medical Shirt Ability to use and populate the mobile app (Zamplo) with or without assistance ECOG: 0-3 Willing to provide a list of analgesic (pain relief) medication Willing to complete questionnaires Life expectancy of at least 3 months Exclusion Criteria: Receiving whole brain radiotherapy Major cognitive or psychiatric impairments Pregnant women Allergies to: polyester, synthetic fibers Patients with pacemakers or implantable cardioverter-defibrillator (ICD) Patients on a Holter Monitor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hexoskin Medical System|Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patient accrual | Feasibility of accruing 100 patients to the study | Over 12 months | 
| Frequency of radiotherapy related adverse events | Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 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. | Baseline to 12 months | 
| Number of Trial Refusals | Evaluate reasons for trial refusal | Baseline to 12 months | 
| Complete follow-ups | Rate of completed follow-ups | Baseline to 12 months | 
| Patient experience and satisfaction | Measure patient experience and satisfaction using mobile app (Zamplo) and Hexoskin | Baseline to 12 months | 
| Patient Adherence | Patient adherence to using the Hexoskin Medical System | Baseline to 12 months | 
| Hexoskin data collection rates | Feasibility of data collection using the Hexoskin Medical System | Baseline to 12 months | 
| Quality of Life (QOL) survey completion | Rate of Quality of Life (QOL) survey completion on mobile app (Zamplo) | Baseline to 12 months | 
| Overall survival of participants | Overall survival time is calculated from study enrollment to date of death or last follow-up | Baseline to 12 months | 
| Characterize adverse event profile | Characterize adverse event profile of various radiotherapy regimens given for metastases | Baseline to 12 months |