Metastatic Cancer, Palliative
Conditions
Brief summary
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
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.
Interventions
DEVICEHexoskin Medical System
Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.
Sponsors
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patient accrual | Over 12 months | Feasibility of accruing 100 patients to the study |
| Frequency of radiotherapy related adverse events | Baseline to 12 months | Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality Adjusted Life Years (QALY) | Baseline to 12 months | 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.) |
| Health Related Quality of Life (QOL) | Baseline to 12 months | Perform Health Related Quality of Life using EORTC QLQ-C30 and rate electronic survey completion. |
| Number of Trial Refusals | Baseline to 12 months | Evaluate reasons for trial refusal |
| Complete follow-ups | Baseline to 12 months | Rate of completed follow-ups |
| Patient experience and satisfaction | Baseline to 12 months | Measure patient experience and satisfaction using mobile app (Zamplo) and Hexoskin |
| Patient Adherence | Baseline to 12 months | Patient adherence to using the Hexoskin Medical System |
| Hexoskin data collection rates | Baseline to 12 months | Feasibility of data collection using the Hexoskin Medical System |
| Quality of Life (QOL) survey completion | Baseline to 12 months | Rate of Quality of Life (QOL) survey completion on mobile app (Zamplo) |
| Overall survival of participants | Baseline to 12 months | Overall survival time is calculated from study enrollment to date of death or last follow-up |
| Characterize adverse event profile | Baseline to 12 months | Characterize adverse event profile of various radiotherapy regimens given for metastases |
Countries
Canada
Contacts
CONTACTPhilip Wong
PRINCIPAL_INVESTIGATORPhilip Wong
The Princess Margaret Cancer Foundation
Outcome results
None listed