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Patient Reported Outcomes/Metrics Program Trial (PROMPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04983199
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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.

Condition or disease Intervention/treatment
Metastatic Cancer Palliative 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation
Actual Study Start Date : November 24, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023
Groups and Cohorts
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Intervention Details:
  • 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.
    Other Name: Hexoskin Smart Shirt

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients planned for palliative radiotherapy to metastatic disease.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04983199


Contacts
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Contact: Philip Wong 416-946-4501 ext 2126 philip.wong@rmp.uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Philip Wong, MD    416-946-4501 ext 2126    philip.wong@rmp.uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Philip Wong The Princess Margaret Cancer Foundation
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04983199    
Other Study ID Numbers: 21-5322
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes