What side effects are associated with this type of intervention?

Common treatments for thoracic conditions, such as inhaled glucocorticoids and beta agonists, can have several side effects. Inhaled glucocorticoids may lead to adrenal suppression, increased risk of infections, and potential for pneumonia, especially in patients with chronic obstructive pulmonary disease (COPD). Beta agonists, particularly when used long-term, can cause tremors, palpitations, and hypokalemia. Systemic therapies, including glucocorticoids and antibiotics, may also contribute to side effects like immunosuppression and gastrointestinal disturbances. Monitoring these side effects through real-time electronic patient-reported outcomes (ePRO) can help in timely management and intervention.

What prior FDA approvals exist?

There are no specific FDA approvals directly related to real-time electronic patient-reported outcome (ePRO) monitoring with automated provider alerts for thoracic conditions. However, the FDA has approved various treatments for thoracic conditions, such as cemiplimab for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression, and other immunotherapies like pembrolizumab. These treatments focus on improving patient outcomes through targeted therapies, although they do not specifically incorporate the ePRO monitoring technology being studied in the trial.

What other types of research exist?

Promising alternatives to ePRO monitoring for thoracic patients include wearable sensors for continuous vital sign monitoring, telehealth platforms with integrated AI for predictive analytics, and mobile health applications that provide personalized treatment recommendations based on real-time data. These technologies can enhance patient management by offering continuous monitoring, early detection of complications, and tailored interventions.

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Behavioural Intervention

ePRO Symptom Monitoring for Thoracic Surgery Patients

N/A

Waitlist Available

Led By Gita Mody, MD, MPH

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be 18 years or older

Patients must be English or Spanish speaking

Must not have

Patients not completing planned surgery within 3 months of obtaining informed consent

Patients with inability to understand English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 4 through 6 after implementation of the study

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on symptom monitoring rather than medication or invasive procedures, traditional side effects aren't expected. However, there may be privacy concerns regarding personal health data management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I speak English or Spanish.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had my planned surgery within 3 months after agreeing to the study.

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I cannot understand English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 4 through 6 after implementation of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 4 through 6 after implementation of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 4 through 6 after implementation of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adoption of ePRO monitoring

Patient-level Uptake

Reach of ePRO monitoring

Secondary study objectives

Alert Rate

Complication Rate

Emergency department visit at 30 days

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ePRO monitoringExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for thoracic conditions, such as chemotherapy, radiotherapy, and immunotherapy, work by targeting cancer cells through different mechanisms: chemotherapy attacks rapidly dividing cells, radiotherapy uses high-energy radiation to destroy cancer cells, and immunotherapy enhances the immune system's ability to fight cancer. The ePRO Monitoring system, which involves real-time electronic patient-reported outcome surveys and automated provider alerts, is crucial as it allows for continuous monitoring and timely intervention, potentially improving patient outcomes and quality of life by ensuring that any concerning symptoms are promptly addressed.

Patterns of care and survival in non small cell lung cancer: 15 years' experience in a general hospital.The effect of consolidation chemotherapy after concurrent chemoradiotherapy on the survival of patients with locally advanced non-small cell lung cancer: a meta-analysis.Patient-Centered Outcome Measures in Lung Cancer Trials.