Patient Reported Outcomes/Metrics Program Trial
PROMPT
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
July 30, 2021
CompletedStudy Start
First participant enrolled
November 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
March 5, 2026
March 1, 2026
4.8 years
July 8, 2021
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Quality Adjusted Life Years (QALY)
Baseline to 12 months
Health Related Quality of Life (QOL)
Baseline to 12 months
Number of Trial Refusals
Baseline to 12 months
Complete follow-ups
Baseline to 12 months
Patient experience and satisfaction
Baseline to 12 months
- +5 more secondary outcomes
Interventions
Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.
Eligibility Criteria
Cancer patients planned for palliative radiotherapy to metastatic disease.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
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.
PMID: 41360655DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip Wong
The Princess Margaret Cancer Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2021
First Posted
July 30, 2021
Study Start
November 24, 2022
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03