ePRO Symptom Monitoring for Thoracic Surgery Patients

Overseen By Amanda Gentry

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Minor surgery, Dementia, Incarceration, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of ePRO monitoring for patients who have undergone major thoracic surgery, involving the chest and lungs. ePRO monitoring requires patients to fill out surveys about their symptoms and physical functioning, which can alert doctors if issues arise. The trial aims to determine if this real-time, remote monitoring can improve recovery. Ideal candidates have had major chest surgery, can complete surveys in English or Spanish, and are recovering at home. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance recovery experiences for future patients.

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

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that ePRO monitoring is safe for thoracic surgery patients?

Research has shown that ePRO monitoring is generally easy for patients to use. Patients fill out surveys online or by phone to report their symptoms. Studies have found that this type of monitoring can be helpful for people with cancer and other conditions, as it tracks symptoms and alerts healthcare providers to any concerning changes.

One study examined ePRO combined with vital sign monitoring and assessed its safety and effectiveness. It found that this approach can improve patients' quality of life. The system allows real-time tracking, enabling doctors to respond quickly if needed.

Overall, ePRO monitoring is considered safe and useful. It helps patients communicate health changes to their care team easily and quickly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ePRO Monitoring for thoracic surgery patients because it offers a novel way to track symptoms remotely using web-based or telephone surveys. Unlike traditional follow-ups that require in-person visits, this approach allows for continuous and real-time monitoring of patient well-being from the comfort of their home. This can lead to quicker detection of post-surgery complications and more personalized care, potentially improving recovery outcomes and patient satisfaction.

What evidence suggests that ePRO monitoring is effective for thoracic surgery patients?

Research has shown that electronic patient-reported outcome (ePRO) monitoring can enhance care for patients who have undergone thoracic surgery. In one study, patients used ePRO to report symptoms electronically, enabling doctors to respond quickly to issues. Another study found that patients using ePRO became more involved in their recovery, leading to better overall outcomes. This trial will involve thoracic surgery patients using ePRO monitoring through web-based or telephone surveys. These findings suggest that ePRO monitoring effectively supports patients after thoracic surgery by keeping doctors informed and engaged in real-time. ^{6 7 8 9 10}

Who Is on the Research Team?

Gita Mody, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults who've had or will have major thoracic surgery, can complete surveys in English or Spanish, and are not pregnant. Excluded are those with minor surgeries, mental conditions affecting consent, prisoners, or if the surgery didn't happen within 3 months after consent.

Inclusion Criteria

I can complete a symptom survey online, by phone, or with a research team member.

I am planning to have or have had major chest surgery within the last 30 days.

Exclusion Criteria

Patients currently incarcerated

Pregnant patients

I have only had minor chest surgeries, like a bronchoscopy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of ePRO monitoring for thoracic surgery patients

3 months

Remote monitoring via web-based or telephone surveys

Monitoring

Participants are monitored using ePRO surveys to track symptoms and trigger alerts

90 days

Continuous remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after the main monitoring phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ePRO Monitoring

Trial Overview The study tests a health tech intervention called ePRO monitoring. It involves patients reporting their symptoms and physical functioning through electronic surveys post-thoracic surgery, which then automatically alert providers to any concerning responses.

How Is the Trial Designed?

Group I: ePRO monitoring Experimental Treatment 1 Intervention

Thoracic surgery patients will be enrolled in ePRO monitoring using web-based or telephone surveys.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 1041 patients undergoing pulmonary cancer surgery, the presence of any postoperative adverse event, even minor ones, significantly increased the likelihood of a prolonged hospital stay, with higher severity events leading to even longer stays.

Factors such as lower lung diffusion capacity and the use of open thoracotomy were also associated with longer hospital stays, highlighting the importance of preoperative assessments and surgical approaches in patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All grades of severity of postoperative adverse events are associated with prolonged length of stay after lung cancer resection. Zhang, Z., Mostofian, F., Ivanovic, J., et al.[2022]

Standardized data collection of postoperative adverse events in thoracic surgery can significantly enhance patient care by documenting and informing practices to reduce complications.

Engaging surgeons in audit and feedback based on this data can lead to consensus recommendations that improve patient outcomes following high-risk surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. Shamji, FM., Gingrich, M., Anstee, C., 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11602354/

A qualitative study of electronic patient-reported outcome ... This study aimed to identify patient-perceived barriers and facilitators to using an electronic patient-reported outcome (ePRO) monitoring ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06075316

Improving Thoracic Surgical Care Using Electronic Patient ... This study evaluates the implementation and effectiveness of perioperative electronic patient-reported outcomes (ePROs) monitoring in thoracic surgery patients.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.11001

based symptom management program (eSyM): A cluster ... Here, we report the primary effectiveness outcome comparing patients treated before (control/not exposed) versus after (intervention/exposed) ...

4. jpro.springeropen.com jpro.springeropen.com/articles/10.1186/s41687-024-00766-0

a qualitative study | Journal of Patient-Reported Outcomes Electronic patient-reported outcome (ePRO) systems can be used to engage patients in remote symptom monitoring to support postoperative care ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11191061/

Electronic Patient-Reported Outcome–Based Symptom ... Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05311670

Pre-Implementation Study of Improving Thoracic Surgical ... Eligible thoracic surgery patients will be enrolled to ePRO monitoring using web-based or telephone surveys. Patients will be asked to self-report symptoms for ...

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

Effectiveness of symptom monitoring on electronic patient ... Symptom monitoring using electronic patient-reported outcomes (ePROs) has demonstrated benefits for patients with cancer, yet the systematic ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837627

Electronic Patient-Reported Outcomes With Vital Sign ... This randomized clinical trial evaluated the effect of ePRO with vital sign monitoring on safety, effectiveness, and QOL in Japanese patients ...

9. withpower.com withpower.com/trial/phase-aortic-dissection-9-2023-fd0b1

ePRO Symptom Monitoring for Thoracic Surgery Patients ePRO Monitoring is unique because it uses electronic patient-reported outcomes to continuously track symptoms and vital signs, allowing for real-time monitoring ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7819459/

Electronic Patient-Reported Outcomes After Thoracic Surgery ePROs may allow us to standardize and streamline a postoperative process, simultaneously reducing hospital visits, improving surgical outcomes, ...