Patient Reported Outcomes/Metrics Program Trial (PROMPT)

Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Cancer; Palliative
• Intervention / Treatment: Device: Hexoskin Medical System

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Philip Wong; Phone Number: 2126 416-946-4501; Email: philip.wong@rmp.uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Philip Wong, MD; Phone Number: 2126 416-946-4501; Email: philip.wong@rmp.uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer patients planned for palliative radiotherapy to metastatic disease.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Philip Wong, The Princess Margaret Cancer Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 21-5322

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No