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

Trial Summary

What is the purpose of this trial?

This clinical trial evaluates earlier symptom management through remote electronic symptom monitoring (such as through an app on patient's phone), and accessibility of palliative care self-referral by patients with thoracic cancer and caregivers by proxy (legal representative). Thoracic cancer occurs in the chest and often causes symptoms for patients. Patients and/or their caregivers are often unable to attend in-person clinic visits for various reasons. The most frequently reported symptom by patients at initial palliative care consultations is pain, and caregivers' most common concerns are pain management for the patient, stress reduction, and fears about patient decline. Earlier palliative care referral can help control these symptoms before they worsen, providing a better quality of life for patients and caregivers. improve physical and emotional functioning for patients and caregivers in cancer care. This study may help researchers learn how an electronic symptom monitoring program may provide an earlier and more accessible way for patients with thoracic cancer to receive palliative care.

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 data supports the effectiveness of the treatment Electronic Symptom Monitoring Program for lung cancer?

Electronic patient-reported outcome (ePRO) systems, which are part of electronic symptom monitoring, have shown benefits in improving quality of life and survival for cancer patients in controlled trials. These systems help in real-time symptom monitoring and can enhance patient safety and outcomes, especially after hospital discharge. ^{1 2 3 4 5}

Is electronic symptom monitoring safe for use in humans?

The research does not provide specific safety data for electronic symptom monitoring, but it is generally used to improve symptom management and quality of life in cancer patients, suggesting it is considered safe for routine use. ^{1 2 3 5 6}

How is the Electronic Symptom Monitoring Program different from other treatments for lung cancer?

The Electronic Symptom Monitoring Program is unique because it uses digital tools to track and report symptoms directly from patients, allowing for timely detection of health risks and earlier interventions, which can improve quality of life and survival in cancer patients. ^{1 2 3 5 6}

Research Team

Julia L Agne, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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) 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. [2021]

2. 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]

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. England 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. [2021]

5. Canada 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. [2021]

6. Switzerland 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. [2023]