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NCT Number: NCT04983199

Patient Reported Outcomes/Metrics Program Trial

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.

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Key information

Conditions

Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Palliative Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location status: Recruiting

Location contact

Philip Wong, MD

CONTACT

[email protected]

416-946-4501 ext. 2126

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hexoskin Medical System

Device

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

Other names: Hexoskin Smart Shirt

Primary outcomes

  1. Rate of patient accrual

    Time frame: Over 12 months

    Feasibility of accruing 100 patients to the study

  2. 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

  1. Quality Adjusted Life Years (QALY)

    Time frame: Baseline to 12 months

    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.)

  2. Health Related Quality of Life (QOL)

    Time frame: Baseline to 12 months

    Perform Health Related Quality of Life using EORTC QLQ-C30 and rate electronic survey completion.

  3. Number of Trial Refusals

    Time frame: Baseline to 12 months

    Evaluate reasons for trial refusal

  4. Complete follow-ups

    Time frame: Baseline to 12 months

    Rate of completed follow-ups

  5. Patient experience and satisfaction

    Time frame: Baseline to 12 months

    Measure patient experience and satisfaction using mobile app (Zamplo) and Hexoskin

  6. Patient Adherence

    Time frame: Baseline to 12 months

    Patient adherence to using the Hexoskin Medical System

  7. Hexoskin data collection rates

    Time frame: Baseline to 12 months

    Feasibility of data collection using the Hexoskin Medical System

  8. Quality of Life (QOL) survey completion

    Time frame: Baseline to 12 months

    Rate of Quality of Life (QOL) survey completion on mobile app (Zamplo)

  9. Overall survival of participants

    Time frame: Baseline to 12 months

    Overall survival time is calculated from study enrollment to date of death or last follow-up

  10. Characterize adverse event profile

    Time frame: Baseline to 12 months

    Characterize adverse event profile of various radiotherapy regimens given for metastases

Study contacts

Contact information is provided by the study sponsor or research team.

Philip Wong

CONTACT

[email protected]

416-946-4501 ext. 2126

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation

Acronym: PROMPT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 30, 2021
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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