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| ID | Type | Description | Link |
|---|---|---|---|
| JT 10294 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Health Care Originals, Inc. | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Feasibility (ADAMM) | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monitoring Device | Device | Wear ADAMM |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with metastatic and non-metastatic lung cancer being treated with radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Maria Werner-Wasik, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |