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

105 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a system where thoracic surgery patients fill out electronic surveys about their health after surgery. If any serious issues are reported, doctors are alerted right away. This aims to catch problems early and reduce severe complications.

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 data supports the effectiveness of the treatment ePRO Monitoring for thoracic surgery patients?

Research shows that using electronic patient-reported outcome (ePRO) systems for symptom monitoring can help detect complications early and improve symptom control after surgery, as seen in studies involving cancer-related surgeries and lung cancer patients. ^{1 2 3 4 5}

Is ePRO symptom monitoring safe for thoracic surgery patients?

Electronic patient-reported outcome (ePRO) systems are used to monitor symptoms in real-time after surgery, which can help detect complications early and improve patient safety. While specific safety data for thoracic surgery patients using ePRO is not detailed, these systems are generally considered safe for monitoring symptoms in various surgical settings. ^{1 6 7 8 9}

How does ePRO Monitoring differ from other treatments 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 and early intervention if needed. This approach is different from traditional methods that may rely on less frequent, manual checks and can help prevent complications by alerting clinicians to changes in a patient's condition more quickly. ^{10 11 12 13 14}

Research Team

Gita Mody, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

References

1. 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]

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

Automated symptom alerts reduce postoperative symptom severity after cancer surgery: a randomized controlled clinical trial. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Shortness of Breath on Day 1 After Surgery Alerting the Presence of Early Respiratory Complications After Surgery in Lung Cancer Patients. [2022]

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

Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events and Length of Stay on Patient Experience After Lung Cancer Resection. [2022]

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

All grades of severity of postoperative adverse events are associated with prolonged length of stay after lung cancer resection. [2022]

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

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Protocol for the ASTRO study (SSOP-01): a multicentre prospective cohort study investigating adverse events based on electronic patient-reported outcomes in patients with breast cancer after adjuvant chemotherapy. [2023]

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

Exercise capacity of thoracotomy patients in the early postoperative period. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Insights into postoperative respiration by using continuous wireless monitoring of respiratory rate on the postoperative ward: a cohort study. [2021]

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

Evaluation of a respiratory rate monitor in postsurgical patients. [2019]

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

A clinical evaluation of pulse oximetry during thoracic surgery. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)-a randomized controlled pilot trial. [2022]