NCT06342284 · The New York Proton Center
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
(PGHD)
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
Proton Beam Radiation with or without concurrent chemotherapy
Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy
Primary outcome measures
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.
Time frame: 4-5 Weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Ability to complete study surveys in English or Spanish
- Age \>/= 18
- Concurrent enrollment on other trials is permitted
- Patients who already use wearable devices and/or smartphones that monitor physical activity are eligible for this trial, provided they agree to utilize the devices provided by the study team during the study period
- All patients must sign study-specific informed consent prior to study entry
Exclusion criteria
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations