Clinical trial NCT04983199: Patient Reported Outcomes/Metrics Program Trial
Official title: Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Cancer
Palliative
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients planned for palliative radiotherapy to metastatic disease.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of patient accrual
timeFrame: Over 12 months
measure: Frequency of radiotherapy related adverse events
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Quality Adjusted Life Years (QALY)
timeFrame: Baseline to 12 months
measure: Health Related Quality of Life (QOL)
timeFrame: Baseline to 12 months
measure: Number of Trial Refusals
timeFrame: Baseline to 12 months
measure: Complete follow-ups
timeFrame: Baseline to 12 months
measure: Patient experience and satisfaction
timeFrame: Baseline to 12 months
measure: Patient Adherence
timeFrame: Baseline to 12 months
measure: Hexoskin data collection rates
timeFrame: Baseline to 12 months
measure: Quality of Life (QOL) survey completion
timeFrame: Baseline to 12 months
measure: Overall survival of participants
timeFrame: Baseline to 12 months
measure: Characterize adverse event profile
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: The Princess Margaret Cancer Foundation
name: Philip Wong
role: PRINCIPAL_INVESTIGATOR
References: