Metastatic CancerPROMPTNCT04983199
Patient Reported Outcomes/Metrics Program Trial
An observational study of Metastatic Cancer and Palliative, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer, Palliative
- What is being tested?
- Hexoskin Medical System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2022to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients planned for palliative radiotherapy to metastatic disease.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Philip Wong, MD, 416-946-4501 ext. 2126, philip.wong@rmp.uhn.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Cancer, Palliative
- Being tested
- Hexoskin Medical System
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexoskin Medical SystemDevice
Also called Hexoskin Smart Shirt
Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patient accrual
Feasibility of accruing 100 patients to the study
Measured: Over 12 months
Frequency of radiotherapy related adverse events
Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring.
Measured: Baseline to 12 months
Secondary outcomes (10)
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.)
Measured: 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.
Measured: Baseline to 12 months
Number of Trial Refusals
Evaluate reasons for trial refusal
Measured: Baseline to 12 months
Complete follow-ups
Rate of completed follow-ups
Measured: Baseline to 12 months
Patient experience and satisfaction
Measure patient experience and satisfaction using mobile app (Zamplo) and Hexoskin
Measured: Baseline to 12 months
Patient Adherence
Patient adherence to using the Hexoskin Medical System
Measured: Baseline to 12 months
Hexoskin data collection rates
Feasibility of data collection using the Hexoskin Medical System
Measured: Baseline to 12 months
Quality of Life (QOL) survey completion
Rate of Quality of Life (QOL) survey completion on mobile app (Zamplo)
Measured: Baseline to 12 months
Overall survival of participants
Overall survival time is calculated from study enrollment to date of death or last follow-up
Measured: Baseline to 12 months
Characterize adverse event profile
Characterize adverse event profile of various radiotherapy regimens given for metastases
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start24 Nov 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip Wong, Principal investigator, The Princess Margaret Cancer Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983199
- Sponsor's protocol ID
- 21-5322
- Acronym
- PROMPT
- Status last verified
- Mar 2026
- First submitted
- 8 Jul 2021
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 41360655
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation
- ClinicalTrials.gov ID
- NCT04983199
- Acronym / sponsor ID
- PROMPT / 21-5322
- Conditions
- Metastatic Cancer, Palliative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients planned for palliative radiotherapy to metastatic disease.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Receiving whole brain radiotherapy
- Major cognitive or psychiatric impairments
- Pregnant women
- Allergies to: polyester, synthetic fibers
- Patients with pacemakers or implantable cardioverter-defibrillator (ICD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hexoskin Medical SystemAlso: Hexoskin Smart ShirtHexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy. | Device | – |
Primary outcome
Rate of patient accrual
Time frame: Over 12 months
Feasibility of accruing 100 patients to the study
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Derived from this study: PubMed 41360655Othman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Wong principal investigator
The Princess Margaret Cancer Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Palliative, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Wong (416-946-4501 ext. 2126, philip.wong@rmp.uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patient accrual (time frame: Over 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04983199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.