Patient Reported Outcomes/Metrics Program Trial (PROMPT)-palliative radiation: protocol of a prospective observational feasibility study.

Abstract

Background: Palliative radiotherapy (RT) is commonly used to relieve symptoms and improve quality of life (QOL) for patients with metastatic cancer. Timely recognition of treatment related symptoms and adverse events (AEs), however, remains challenging, as reporting often depends on clinic visits and patient recall. This study explores the feasibility of integrating biometric monitoring, specifically the smart shirt from the Hexoskin Medical System (HMS), to monitor patients with metastatic cancer receiving palliative RT for symptom management. This is complemented by Zamplo, a digital health platform to allow patients and caregivers to report symptoms and well-being.

Methods: The PROMPT trial is a prospective observational feasibility study that aims to recruit 100 patients with metastatic cancer undergoing palliative RT. Adult patients with a confirmed cancer diagnosis who can wear the HMS shirt and use the Zamplo platform are included. To improve accessibility and trial opportunity, patients are fitted with one of 11 sex-adjusted HMS shirt sizes, provided a smartphone, and taught to use Zamplo account. Patients are encouraged to wear the HMS shirt for a minimum of 4 hours daily at baseline, during RT and periodically during follow-up. Patient-reported outcomes (PROs) are being collected using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the EuroQol 5-Dimension 5-Level, the Person-Centred Coordinated Care Experiences Questionnaire for Cancer Patients (PCC-CA-6), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events through Zamplo at baseline and on days 30, 90 and 365, and through ad-hoc patient entries. Zamplo data are complemented with routine clinical symptom screening using ESAS. The primary endpoint is to recruit 100 patients within a 12-month period and to report the frequency of grade 2 or above AEs within 30 days of RT.

Discussion: HMS shirt may improve detection and timely management of RT-related AEs and help identify key biometric variables that predict or correspond to AEs and changes in patient well-being. Whereas patients typically accept wearing wrist-worn activity trackers (ATs), this study will determine whether remote monitoring using the HMS shirt is acceptable and feasible in a palliative cancer population.

Trial registration: ClinicalTrials.gov, NCT04983199.