Trial results for the PROStep feasibility study, monitoring patients with Lung Cancer and Gastro-intestinal cancers, were posted on ClinicalTrials.gov on 2025-07-02, involving 108 participants.
Background
Lung cancer and gastrointestinal cancers represent significant health challenges, often requiring complex and ongoing care. Remote monitoring, utilizing telemedicine and patient-reported outcomes (PROs), has emerged as a crucial tool to provide continuous care, especially for vulnerable cancer patient populations. The PROStep trial explored the feasibility of using PROs and step data to monitor patients, aiming to enhance care while minimizing risks, particularly in the context of infectious disease outbreaks like COVID-19.
Trial design
This completed Phase 3 study enrolled 108 participants with conditions including Cancer, Lung Cancer, and Gastro-intestinal. The PROStep trial investigated the feasibility of remote monitoring for cancer patients through weekly patient-reported outcome (PRO) collection via a smartphone application and step data from wearables. The study included a control arm (Arm A) and intervention arms, one without text feedback (Arm B) and another with text feedback (Arm C).
Key results
The trial reported several key measurements related to patient perceptions of care:
- Patient Perceptions of Symptom Management - How Well do You Feel Your Oncology Team Understands Your Symptoms (e.g. Nausea, Vomiting, Weight Loss, Etc.)?
- For Arm A, a mean score of 4.5 (Standard Deviation 1) units on a scale was observed.
- For Arms B+C, a mean score of 4.5 (Standard Deviation 1) units on a scale was observed.
- Patient Perception of Functional Status - How Well do You Feel Your Oncology Team Understands Your Activity Level and Ability to Function? (1-5)
- For Arm A, a mean score of 4.5 (Standard Deviation .9) units on a scale was observed.
- For Arms B+C, a mean score of 4.3 (Standard Deviation 1) units on a scale was observed.
- Additional Analysis of the Primary Outcome Between Arms
- For Arm A - Control, a mean score of 4.5 (Standard Deviation 1) units on a scale was observed.
- For Arm B - Intervention Without Text Feedback, a mean score of 4.5 (Standard Deviation 1) units on a scale was observed.
- For Arm C - Intervention With Text Feedback, a mean score of 4.4 (Standard Deviation 1.2) units on a scale was observed.
- For Arm A - Control, a mean score of 4.4 (Standard Deviation .9) units on a scale was observed.
- For Arm B - Intervention Without Text Feedback, a mean score of 4.5 (Standard Deviation .9) units on a scale was observed.
- For Arm C - Intervention With Text Feedback, a mean score of 4.3 (Standard Deviation 1.1) units on a scale was observed.
What this means
The results indicate generally positive patient perceptions regarding their oncology team's understanding of symptoms and functional status. Across various arms, mean scores ranged from 4.3 to 4.5 on a 5-point scale, with standard deviations typically around 1. These findings suggest that the remote monitoring approach, which included PRO collection and step data, was associated with patients feeling well-understood by their care teams. As a feasibility trial, these data provide insights into patient experiences with such monitoring systems in cancer care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04616768, titled "PROStep: A Feasibility Trial Using PROs and Step Data to Monitor Patients With Lung and GI Cancers", were posted on 2025-07-02 on clinicaltrials.gov.