Home ePRO System for Cancer

Overseen By Valerie M Lawhon, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Second opinion only

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

7500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Home ePRO System to assist cancer patients in managing their treatment journey. The goal is to evaluate how effectively this system, delivered by a navigator (a person who guides patients), helps patients track their symptoms and treatment effects from home. Researchers aim to understand what factors make the system easy or difficult to use and how it impacts health and medical visits. Patients receiving chemotherapy, targeted therapy, or immunotherapy for cancer at a participating institution might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for cancer care management.

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 prior data suggests that the Home ePRO System is safe for cancer patients?

Research shows that the navigator-delivered ePRO System is generally safe for patients. Studies have found that using this system to track symptoms at home can reduce hospital visits for cancer patients. Patients can use the system without major side effects. Additionally, research has found that ePRO systems improve patients' quality of life, helping them feel better overall. No reports of serious side effects have emerged, which reassures those considering joining a trial with this system. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Navigator-delivered ePRO System because it offers a new way to support cancer patients from home. Unlike traditional treatments that require frequent hospital visits for monitoring, this system allows patients to report their symptoms and progress electronically, providing real-time data to healthcare providers. This remote monitoring can lead to quicker adjustments in treatment plans and potentially improve patient outcomes by catching issues early. It also reduces the burden on patients by minimizing the need for in-person appointments, making cancer care more convenient and accessible.

What evidence suggests that the Home ePRO System is effective for cancer patients?

Research has shown that using an electronic system for reporting health issues (ePRO) can help cancer patients feel better and manage their symptoms more effectively. In this trial, participants will use the Navigator-delivered ePRO System. Studies have found that patients using these systems enjoy a better quality of life and have improved control over their symptoms. For example, one study discovered that monitoring symptoms remotely with ePRO reduced the chances of cancer patients needing to go to the hospital. This results in fewer hospital visits and better symptom management from home. Overall, these systems help patients track their health and communicate more easily with their healthcare team. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Patient Group Experimental Treatment 1 Intervention

7,500 Patients from UAB/MCI

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+

Published Research Related to This Trial

The Advanced Symptom Management System (ASyMS) significantly reduced symptom burden in patients undergoing adjuvant chemotherapy, keeping their symptoms at pre-treatment levels, while those receiving standard care experienced increased symptoms throughout treatment.

Patients using ASyMS reported better quality of life and lower anxiety levels compared to the control group, indicating that remote monitoring can enhance patient support during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). Maguire, R., McCann, L., Kotronoulas, G., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The study focuses on using an electronic Patient-Reported Outcome (ePRO) platform to measure and manage symptom burden in outpatients with advanced cancers, including lung, stomach, and breast cancer, with the primary goal of assessing changes in symptom burden over time.

The methodology includes using various validated symptom assessment tools and sending automated follow-up notifications to patients over 4 weeks, aiming to evaluate the feasibility of the ePRO system in tracking symptoms and improving patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol. Tang, L., Pang, Y., He, Y., et al.[2021]

An online platform for collecting patient-reported outcomes (PROs) in chemotherapy patients was found to be highly feasible, with 85% of patients using it during follow-up visits over 16 months, indicating strong acceptance and satisfaction from both patients and clinicians.

The system's alert feature effectively facilitated timely clinical responses, such as delaying treatments or modifying doses based on reported serious toxicities, potentially enhancing patient safety and care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. Basch, E., Artz, D., Iasonos, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? Denis, F., Krakowski, I.[2021]

The implementation of electronic patient-reported outcomes (ePROs) in a large community oncology network showed high initial utilization, with 73% of enrolled patients completing at least one assessment, indicating that ePROs can effectively monitor symptoms during chemotherapy.

However, compliance with ePRO assessments declined over time, from 72% to 52% over 10 weeks, highlighting the need to address barriers such as reminder prompts and clinician engagement to maintain high levels of participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Electronic Patient-Reported Outcomes for Symptom Monitoring in a Large Multisite Community Oncology Practice: Dancing the Texas Two-Step Through a Pandemic. Patt, D., Wilfong, L., Hudson, KE., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A web-based interface (WBI) for patient symptom self-reporting during chemoradiation therapy was found to be feasible and well-received, with 92% of patients reporting easy access to the surveys.

Despite high satisfaction, survey fatigue was noted, as 58% of patients felt the surveys were too long or frequent, suggesting a need for a more patient-centered approach to improve engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Symptom Monitoring With Patient-Reported Outcomes During Definitive Radiation Therapy With Chemotherapy (SYMPATHY): A Prospective Single-Center Phase 1 Study. Ma, TM., Yang, T., Philipson, R., et al.[2023]

The mobile phone-based Advanced Symptom Management System (ASyMS) significantly reduced reports of fatigue and hand-foot syndrome in patients undergoing chemotherapy compared to a control group, indicating its efficacy in symptom management.

In a randomized controlled trial involving 112 cancer patients, those using ASyMS reported better management of chemotherapy-related symptoms, suggesting that remote monitoring can enhance patient care during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. Kearney, N., McCann, L., Norrie, J., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP.24.00270

Using Electronic Patient-Reported Outcome Monitoring to ... Patients with advanced cancer who receive ePRO symptom monitoring have improved quality of life, better symptom control, and in some cases ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12399665/

Electronic patient-reported outcome systems and capabilities ... Our systematic review of electronic patient-reported outcome (ePRO) systems in cancer care focused on the capabilities of these systems for capturing patient ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833891

Remote Symptom Monitoring With Electronic Patient ... This nonrandomized controlled trial found that RSM implementation was associated with reduced risk of hospitalizations for patients with cancer.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9027833/

a protocol for a hybrid type 2 clinical trial - PMC The navigator will explain the rationale for remote symptom monitoring, help the patient select the e-mail or text option for symptom surveys, ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04809740/evaluating-the-implementation-and-impact-of-navigator-delivered-epro-system

Evaluating the Implementation and Impact of Navigator ... In Aim 1, Home ePRO will be evaluated using implementation outcomes (service penetrance, provider adoption/penetration, intervention fidelity).

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.351

Identification of target population in the implementation ... Identification of target population in the implementation of navigator-delivered home ePRO for patients with cancer receiving treatment.

7. pcori.org pcori.org/implementation-evidence/putting-evidence-work/health-systems-implementation-initiative/monitoring-electronic-patient-reported-outcomes-during-cancer-treatment

Monitoring Electronic Patient-Reported Outcomes During ... A PCORI-funded study compared the use of an electronic patient-reported outcomes (ePROs) system to collect and monitor patient symptoms at home and usual care.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12223247/

Effectiveness of symptom monitoring on electronic patient ... The meta-analysis showed significant improvement in health-related quality of life (SMD = 2.44, P < 0.001) among patients with lung cancer.