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Recruiting NCT04983199

Patient Reported Outcomes/Metrics Program Trial

— Observational Metastatic Cancer Palliative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hexoskin Medical System.
Who it may be relevant to
Registry conditions: Metastatic Cancer, Palliative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation

Overview

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

  • 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.

Primary outcome measures

  • Rate of patient accrual [Time frame: Over 12 months]
  • Frequency of radiotherapy related adverse events [Time frame: Baseline to 12 months]
Secondary outcome measures (10)
  • Quality Adjusted Life Years (QALY) [Time frame: Baseline to 12 months]
  • Health Related Quality of Life (QOL) [Time frame: Baseline to 12 months]
  • Number of Trial Refusals [Time frame: Baseline to 12 months]
  • Complete follow-ups [Time frame: Baseline to 12 months]
  • Patient experience and satisfaction [Time frame: Baseline to 12 months]
  • Patient Adherence [Time frame: Baseline to 12 months]
  • Hexoskin data collection rates [Time frame: Baseline to 12 months]
  • Quality of Life (QOL) survey completion [Time frame: Baseline to 12 months]
  • Overall survival of participants [Time frame: Baseline to 12 months]
  • Characterize adverse event profile [Time frame: Baseline to 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Princess Margaret Cancer Centre — Toronto

Publications

  • Othman H, Hannon B, Liu ZA, Raman S, Sexton E, Kasper C, Auger H, Tsai CJ, Barry A, Wong P. Patient Reported Outcomes/Metrics Program Trial (PROMPT)-palliative radiation: protocol of a prospective observational feasibility study. Ann Palliat Med. 2025 Nov;14(6):570-578. doi: 10.21037/apm-25-19. PMID 41360655

Identifiers

NCT: NCT04983199 · 21-5322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗