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This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards.
This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards.
Primary Objective
• To demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer.
Secondary Objective • To demonstrate the face validity of physical activity and vital sign data collected during proton beam radiotherapy for lung cancer.
Exploratory Objective
• To explore associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Beam Radiation with or without concurrent chemotherapy | Radiation | Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion. | Feasibility assessed based on the quantity of data collected from day of radiotherapy initiation to day of radiotherapy completion. The feasibility of physical activity data collection will be assessed based on usage information provided by the Apple Watch. Descriptive statistics to be used to report the distribution of average use times in the study cohort and the proportion of days subjects wear the Apple Watch for at least 8 hours. The feasibility of daily home pulse oximeter data collection reported using frequencies and percentages. The feasibility of weekly electronic PRO collection reported using frequencies and percentages. | 4-5 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the face validity of physical activity and vital sign data collected in this trial by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics. | Face validity will be evaluated by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics (mean, standard deviation, median, range) and visually using histograms and boxplots. Additionally, the proportion of reported measures outside of the expected range based on subjects' medical conditions and data obtained during clinic visits (i.e., non-physiologic outliers) will be estimated by the study team. Data elements will be deemed to have face validity if less than 5% of the collected values fall outside the expected range. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses. | Inferential statistical analyses carried out in support of this objective will be exploratory, recognizing the feasibility nature of the study, the associated lack of statistical power, and that these analyses are intended to estimate effect sizes to inform future studies. |
Inclusion Criteria:
Exclusion Criteria:
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Patients over the age of 17 years old that will be receiving proton beam thoracic radiotherapy with curative intent for lung cancer.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitin Ohri, MD | Contact | 718-405-8550 | nitin.ohri@einsteinmed.edu | |
| Ryan Holder, BS | Contact | 646-968-9055 | rholder@nyproton.com |
| Name | Affiliation | Role |
|---|---|---|
| Nitin Ohri, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Proton Center | Recruiting | New York | New York | 10035 | United States |
No individual participant data planned to be shared
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| 4-5 Weeks |
| 5 Years |