Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
ConditionThoracic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe New York Proton Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Plan for fractionated (≥15 treatments) proton beam thoracic radiotherapy with curative intent for lung cancer
Non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) histology is permitted.
Concurrent chemotherapy is permitted but not required..
Previous thoracic radiotherapy is allowed.
Disqualifiers
Ongoing treatment for another cancer that is expected to affect the toxicity profile of thoracic radiotherapy
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Trial population
Patients over the age of 17 years old that will be receiving proton beam thoracic radiotherapy with curative intent for lung cancer.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Proton Beam Radiation with or without concurrent chemotherapy
RadiationCurative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
4-5 WeeksSecondary outcomes
1
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.
Time frame
4-5 WeeksOther outcomes
1
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.
Time frame
5 YearsSponsors and contacts
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Source ClinicalTrials.gov