Patient Reported Outcomes/Metrics Program Trial

Metastatic Cancer Clinical Trial

— PROMPT  

Official title:

Patient Reported Outcomes/Metrics Program Trial - Palliative Radiation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04983199
• Other study ID #: 21-5322
• Status: Recruiting
• Start date: November 24, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: Philip Wong
• Phone: 416-946-4501
• Email: philip.wong[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Palliative

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patient accrual	Feasibility of accruing 100 patients to the study	Over 12 months
Primary	Frequency of radiotherapy related adverse events	Frequency of grade 2 or above radiotherapy related adverse events with extended monitoring.	Baseline to 12 months
Secondary	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.)	Baseline to 12 months
Secondary	Health Related Quality of Life (QOL)	Perform Health Related Quality of Life using EORTC QLQ-C30 and rate electronic survey completion.	Baseline to 12 months
Secondary	Number of Trial Refusals	Evaluate reasons for trial refusal	Baseline to 12 months
Secondary	Complete follow-ups	Rate of completed follow-ups	Baseline to 12 months
Secondary	Patient experience and satisfaction	Measure patient experience and satisfaction using mobile app (Zamplo) and Hexoskin	Baseline to 12 months
Secondary	Patient Adherence	Patient adherence to using the Hexoskin Medical System	Baseline to 12 months
Secondary	Hexoskin data collection rates	Feasibility of data collection using the Hexoskin Medical System	Baseline to 12 months
Secondary	Quality of Life (QOL) survey completion	Rate of Quality of Life (QOL) survey completion on mobile app (Zamplo)	Baseline to 12 months
Secondary	Overall survival of participants	Overall survival time is calculated from study enrollment to date of death or last follow-up	Baseline to 12 months
Secondary	Characterize adverse event profile	Characterize adverse event profile of various radiotherapy regimens given for metastases	Baseline to 12 months