Thoracic CancerPGHDNCT06342284
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
An observational study of Thoracic Cancer, run by The New York Proton Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Cancer
- What is being tested?
- Proton Beam Radiation with or without concurrent chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 21 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 17 years old that will be receiving proton beam thoracic radiotherapy with curative intent for lung cancer.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Proton Center
New York, New York, 10035
Ryan Holder, BS, 646-968-9055, rholder@nyproton.com
Thomas Mistretta, MS, 646-568-5675, tmistretta@nyproton.com
About this study
Official title: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study
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.
Read the detailed 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.
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.
- Conditions
- Thoracic Cancer
- Being tested
- Proton Beam Radiation with or without concurrent chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Beam Radiation with or without concurrent chemotherapyRadiation
Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-5 Weeks
Secondary 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.
Measured: 4-5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start22 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completion21 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New York Proton Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitin Ohri, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342284
- Sponsor's protocol ID
- NYPC ERC# 2021-030
- Acronym
- PGHD
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT06342284
- Acronym / sponsor ID
- PGHD / NYPC ERC# 2021-030
- Conditions
- Thoracic Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The New York Proton CenterUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 21 Mar 2031 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 17 years old that will be receiving proton beam thoracic radiotherapy with curative intent for lung cancer.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proton Beam Radiation with or without concurrent chemotherapyCurative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy | Radiation | – |
Primary outcome
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.
1 secondary outcome
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.
Time frame: 4-5 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. No individual participant data planned to be shared
Related trials for Thoracic Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Ohri, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Cancer, run by The New York Proton Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Ohri, MD (718-405-8550, nitin.ohri@einsteinmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.