Clinical trial · Observational
Patient Reported Outcomes/Metrics Program Trial
Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation
NCT04983199CI-TRIAL-00104691PROMPTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Palliative | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexoskin Medical System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Rate of patient accrual
- timeFrame
- Over 12 months
- description
- Feasibility of accruing 100 patients to the study
- measure
- Frequency of radiotherapy related adverse events
- timeFrame
- Baseline to 12 months
- description
- Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring.
Secondary outcomes (10)
- measure
- Quality Adjusted Life Years (QALY)
- timeFrame
- Baseline to 12 months
- description
- 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.)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOthman 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 41360655