7500 Participants Needed

Home ePRO System for Cancer

SA
VM
Overseen ByValerie M Lawhon, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

1) Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current treatments, as the trial involves patients already receiving chemotherapy, targeted therapy, and immunotherapy.

What data supports the effectiveness of the Home ePRO System for Cancer treatment?

Research shows that using electronic patient-reported outcomes (ePRO) systems for symptom monitoring in cancer patients can lead to better quality of life and improved survival rates. Additionally, ePRO systems have been associated with better clinical outcomes and higher patient satisfaction during chemotherapy.12345

Is the Home ePRO System for Cancer safe for humans?

Research on similar systems, like the Advanced Symptom Management System (ASyMS) and other electronic patient-reported outcomes (ePRO) platforms, shows they are generally safe and well-accepted by patients and clinicians. These systems help monitor symptoms during cancer treatment and have been used without major safety concerns, improving patient satisfaction and care.26789

How is the Home ePRO System for Cancer different from other treatments?

The Home ePRO System for Cancer is unique because it uses electronic patient-reported outcomes (ePRO) to remotely monitor symptoms, which can improve quality of life and survival for cancer patients. Unlike traditional treatments that focus solely on medication, this system allows for real-time symptom tracking and management, enhancing patient care through technology.23567

Eligibility Criteria

This trial is for cancer patients aged 18 or older who are receiving chemotherapy, targeted therapy, or immunotherapy at the participating institution from 2019 to 2026. It's designed to assess a home electronic Patient-Reported Outcomes (ePRO) system.

Inclusion Criteria

I am a cancer patient at a participating hospital or clinic.
I received cancer treatment at this hospital between 2019 and 2026.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of navigator-delivered Home ePRO for all cancer patients receiving chemotherapy

5 years
Ongoing monitoring through electronic systems

Evaluation

Evaluation of implementation outcomes, barriers, facilitators, and patient-level outcomes

5 years

Follow-up

Participants are monitored for safety and effectiveness after implementation

6 months

Treatment Details

Interventions

  • Navigator-delivered ePRO System
Trial Overview The study evaluates how well a navigator helps cancer patients use an ePRO system at home across different sites. It looks into what makes it easier or harder to implement this system and its effects on patient care and healthcare usage.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patient GroupExperimental Treatment1 Intervention
7,500 Patients from UAB/MCI

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

University of South Alabama

Collaborator

Trials
44
Recruited
15,800+

Findings from Research

In a study involving 79 cancer patients (30 Black and 49 White), electronic patient-reported outcomes (ePROs) were found to be valuable for symptom monitoring, with Black patients reporting greater benefits in facilitating discussions with clinicians compared to White patients.
While most participants preferred a web-based system, Black patients showed a higher preference for automated telephone options and paper-based formats, indicating the need for diverse ePRO options to accommodate varying e-health literacy levels among patients.
Racial differences in user experiences and perceived value of electronic symptom monitoring in a cohort of black and white bladder and prostate cancer patients.Samuel, CA., Smith, AB., Elkins, W., et al.[2022]
A pilot study involving 13 patients and 5 oncology staff demonstrated that using an electronic patient-reported outcomes (ePRO) platform for monitoring symptoms in cancer patients is feasible, with a high compliance rate of 91% for weekly assessments.
The majority of participants found the ePRO app helpful, with 87% of patients and 100% of staff expressing a willingness to use it frequently, indicating strong potential for improving symptom management in cancer care.
A pilot project investigating the use of ONCOpatient®-An electronic patient-reported outcomes app for oncology patients.Macanovic, B., O'Reilly, D., Harvey, H., et al.[2023]
Electronic patient-reported outcome (ePRO) systems have demonstrated benefits in quality of life and survival for cancer patients in controlled trials, indicating their potential effectiveness in routine oncology practice.
Clinicians should ask specific questions about the effectiveness, safety, and functionality of ePRO systems when selecting software solutions to ensure they choose the best tools for their patients.
How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer?Denis, F., Krakowski, I.[2021]

References

Racial differences in user experiences and perceived value of electronic symptom monitoring in a cohort of black and white bladder and prostate cancer patients. [2022]
A pilot project investigating the use of ONCOpatient®-An electronic patient-reported outcomes app for oncology patients. [2023]
How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? [2021]
Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multisite Community Oncology Practice: Dancing the Texas Two-Step Through a Pandemic. [2022]
Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol. [2021]
Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). [2021]
Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. [2022]
Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. [2022]
Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study. [2023]
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