Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Rate of patient accrual
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Rate of patient accrual
Time Frame: Over 12 months
Feasibility of accruing 100 patients to the study
Frequency of radiotherapy related adverse events
Time Frame: Baseline to 12 months
Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring.
Secondary Outcomes
- Number of Trial Refusals(Baseline to 12 months)
- Quality of Life (QOL) survey completion(Baseline to 12 months)
- Characterize adverse event profile(Baseline to 12 months)
- Complete follow-ups(Baseline to 12 months)
- Quality Adjusted Life Years (QALY)(Baseline to 12 months)
- Hexoskin data collection rates(Baseline to 12 months)
- Patient Adherence(Baseline to 12 months)
- Health Related Quality of Life (QOL)(Baseline to 12 months)
- Overall survival of participants(Baseline to 12 months)
- Patient experience and satisfaction(Baseline to 12 months)