Electronic Symptom Monitoring for Lung Cancer

Overseen By The Ohio State Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Prior palliative care, Prisoners, Pregnant, others

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

157 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people with lung cancer manage their symptoms using an app called the Electronic Symptom Monitoring Program. The goal is to determine if tracking symptoms on a phone or other device can help patients receive palliative care (specialized medical care focused on symptom relief) sooner. This may lead to better pain management, reduced stress, and improved quality of life. The trial seeks participants with lung cancer who have had at least two visits to the Ohio State University Comprehensive Cancer Center, along with their caregivers who can access email or text messages. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance symptom management and improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this electronic symptom monitoring program is safe for patients with thoracic cancer?

Research has shown that electronic symptom monitoring programs are generally safe and well-liked by patients. For instance, one study found that cancer patients using this type of program felt safe and empowered due to ongoing monitoring and timely support. This indicates that the system is not only safe but also beneficial for patients.

Another study discovered that remote symptom monitoring reduced hospital visits for cancer patients. This suggests that the program can effectively manage symptoms at home, decreasing the need for more intensive medical care.

Overall, these programs have improved the quality of life for patients with lung cancer. They help catch symptoms early and allow for quicker responses to any changes in health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electronic Symptom Monitoring Program for lung cancer because it offers a new way to keep track of symptoms through technology. Unlike traditional treatments that primarily focus on medication and physical interventions, this program leverages digital tools to help patients and caregivers log symptoms weekly. This approach allows for real-time symptom tracking and potentially faster response to changes in a patient’s condition, which could improve overall care and patient outcomes. Additionally, the inclusion of educational materials and videos empowers patients and caregivers, fostering a more proactive role in managing the disease.

What evidence suggests that this electronic symptom monitoring program is effective for thoracic cancer?

Research has shown that electronic tools for tracking symptoms can greatly improve the quality of life for people with lung cancer. In this trial, participants will use an electronic symptom monitoring program as part of supportive care. One study found that this method significantly boosted patients' health and well-being. Another study discovered that remote symptom tracking led to fewer hospital visits for cancer patients. Additionally, starting electronic monitoring soon after lung cancer surgery reduced symptoms and improved patients' ability to function for up to a year. These findings suggest that electronic symptom tracking might effectively manage symptoms and enhance life quality for those with lung cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Julia L Agne, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with thoracic cancer, which affects the chest area, and their caregivers. It's designed to help those who can't always make it to in-person clinic visits. Participants will use an electronic system to monitor symptoms like pain and receive palliative care advice remotely.

Inclusion Criteria

Ability to read and understand English

≥ 2 visits at the Ohio State University Comprehensive Cancer Center (OSUCCC) Thoracic Oncology Clinic

I can understand and am willing to sign the consent form.

Exclusion Criteria

Prisoners are excluded from participation

Pregnant patients are excluded from participation

I am able to make my own medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Preparation

Participants watch a video and review educational materials prior to starting the remote symptom monitoring program

1 week

Symptom Monitoring

Participants use the electronic symptom monitoring program to log symptoms weekly

24 weeks

Weekly remote logging

Follow-up

Participants are monitored for palliative care referral patterns and symptom management effectiveness

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Symptom Monitoring Program

Trial Overview The study tests a remote electronic symptom monitoring program that allows patients or their caregivers to report on symptoms via an app. The goal is to see if this leads to earlier palliative care referrals, potentially improving patient quality of life and caregiver stress levels.

How Is the Trial Designed?

Group I: Supportive Care (electronic symptom monitoring program) Experimental Treatment 5 Interventions

Patients and their caregivers participate use the electronic symptom monitoring program to log symptoms QW for 24 weeks. Patients and their caregivers also watch a video and review education materials prior to starting the remote symptom monitoring program.

Electronic Symptom Monitoring Program is already approved in United States, European Union for the following indications:

Approved in United States as Electronic Symptom Monitoring Program for:

• Thoracic cancer symptom management
• Palliative care referrals

Approved in European Union as Electronic Symptom Monitoring Program for:

• Thoracic cancer symptom management
• Palliative care referrals

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Published Research Related to This Trial

In a study involving 181 cancer patients, the agreement between patient-reported symptoms and physician assessments showed moderate reliability, particularly for symptoms reported within a week of review, indicating that electronic patient-reported outcomes (ePRO) can be a valuable tool in clinical practice.

The study found that shared monitoring of symptoms between patients and physicians can enhance understanding and management of symptoms, suggesting that integrating ePRO into cancer care may lead to better patient empowerment and timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient- and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial. Trojan, A., Leuthold, N., Thomssen, C., et al.[2021]

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 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]

Electronic patient-reported outcome (ePRO) applications can significantly enhance cancer survivorship care by monitoring symptoms and providing insights into patients' well-being, which helps identify unmet needs throughout their treatment journey.

ePRO-symptom monitoring facilitates timely health risk detection and allows for earlier interventions, improving communication between patients and healthcare providers during consultations, although there are important ethical considerations regarding privacy and data representation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review on the Collection and Use of Electronic Patient-Reported Outcomes in Cancer Survivorship Care with Emphasis on Symptom Monitoring. van den Hurk, CJG., Mols, F., Eicher, M., et al.[2023]

The study compared two versions of a mobile app for monitoring cancer patients' symptoms, finding that version 2 significantly increased the number of daily data entries for well-being (0.3 to 1.0) and symptoms (1.3 to 1.9), indicating improved engagement.

Version 2 of the app, which included a feature for collaborative patient-doctor symptom reviews, resulted in 628 out of 872 intended reviews being completed, suggesting that this collaborative approach enhances the quality of data collected and the patient-doctor experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. Trojan, A., Bättig, B., Mannhart, M., et al.[2021]

A pilot study involving 40 patients who underwent cancer-related upper gastrointestinal surgery demonstrated that an electronic patient-reported outcome (ePRO) system is feasible and acceptable for real-time symptom monitoring after discharge.

The ePRO system effectively triggered tailored self-management advice and clinician alerts based on patient-reported symptoms, indicating its potential to enhance patient safety and support recovery, though further research is needed to assess its overall impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-time electronic symptom monitoring system for patients after discharge following surgery: a pilot study in cancer-related surgery. Richards, HS., Blazeby, JM., Portal, A., et al.[2021]

Citations

1. nature.com nature.com/articles/s41746-025-01812-x

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.

2. 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.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40604235/

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.

4. becarispublishing.com becarispublishing.com/doi/10.57264/cer-2024-0122

Real-world ePRO use and clinical outcomes ... Remote symptom monitoring using electronic patient-reported outcome (ePRO) tools could help patients to communicate easily with healthcare ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.01854

Electronic Patient-Reported Outcome–Based Symptom ... Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0749208125000968

Results from the IePRO Randomized Controlled Trial The IePRO MoC was reported to be an acceptable intervention. Patients expressed feeling safe and empowered due to continuous monitoring and timely support from ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12076171/

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, ...

8. 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.