Automated Device for Asthma Monitoring and Management in Monitoring Adults With Lung Cancer Undergoing Radiation Therapy

Study Overview
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Brief Summary
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This pilot early phase I trial studies the Automated Device for Asthma Monitoring and Management in monitoring adult patients with lung cancer who are undergoing radiation therapy. The Automated Device for Asthma Monitoring and Management may provide useful information to doctors to help monitor adult patients with lung cancer and diagnose certain conditions earlier than traditional means.

Detailed Description
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PRIMARY OBJECTIVES: I. Determine compliance with the Automated Device for Asthma Monitoring and Management (ADAMM) device in patients receiving radiation therapy (RT) for lung cancer. SECONDARY OBJECTIVES: I. Evaluate feasibility of recruitment, acceptability of the ADAMM device, and compliance with electronic patient-reported outcomes (ePROs) in this patient population

Official Title
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A Pilot Study Investigating the Feasibility of ADAMM (Automated Device for Asthma Monitoring and Management) in Combination With Electronic Patient-Reported Outcomes in Adult Patients With Lung Cancer

Conditions
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Lung Carcinoma

Intervention / Treatment
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* Device: Monitoring Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are capable of giving informed consent Patients are eligible to be treated with RT and plan to start treatment Patients have either metastatic or non-metastatic lung cancer as defined in history and physical Patients must be able to read or speak English Women of reproductive potential should have a negative serum or urine pregnancy test within one week prior to radiation planning CT scan Exclusion Criteria: Patients who cannot read or speak English Patients who are not candidates for RT treatment Women of childbearing potential who are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Feasibility (ADAMM)<br>Patients wear the Automated Device for Asthma Monitoring and Management (ADAMM) from the time of computed tomography (CT) simulation for radiation therapy (RT) planning throughout the entire RT course and for 4 weeks post-RT | Device: Monitoring Device<br>* Wear ADAMM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of hours per day that patients wear the Automated Device for Asthma Monitoring and Management device | The compliance rate along with a one-sided exact 95% confidence interval will be estimated. | Up to 4 weeks post-radiation therapy | 
| Percentage of days per study period that patients wear the Automated Device for Asthma Monitoring and Management device | The compliance rate along with a one-sided exact 95% confidence interval will be estimated. | Up to 4 weeks post-radiation therapy |