Patient Reported Outcomes/Metrics Program Trial

NCT ID: NCT04983199

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-24

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Metastatic Cancer Palliative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Hexoskin Medical System

Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.

Intervention Type DEVICE

Other Intervention Names

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Hexoskin Smart Shirt

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip Wong

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Philip Wong

Role: CONTACT

416-946-4501 ext. 2126

Facility Contacts

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Philip Wong, MD

Role: primary

416-946-4501 ext. 2126

Other Identifiers

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21-5322

Identifier Type: -

Identifier Source: org_study_id

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