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

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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

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. ^{2 3 5 6 7}

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A pilot project investigating the use of ONCOpatient®-An electronic patient-reported outcomes app for oncology patients. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? [2021]

4. United States 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. [2022]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of an online platform for cancer patient self-reporting of chemotherapy toxicities. [2022]

9. United States 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. [2023]