Collecting health data from lung cancer patients during proton therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect patient-generated health data from individuals undergoing proton beam radiotherapy for lung cancer using devices like an Apple Watch and a home pulse oximeter. The data collection will occur from the day of enrollment until two weeks after the completion of radiotherapy, with participants also completing a satisfaction survey at the end of the study period. The study will explore the feasibility of this data collection approach and examine associations between treatment parameters, wearable device data, and patient-reported outcomes.

Why it matters

Who can join: the full rules

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 it's running

• New York Proton Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Nitin Ohri, MD — Montefiore Medical Center
• Study coordinator: Nitin Ohri, MD
• Email: nitin.ohri@einsteinmed.edu
• Phone: 718-405-8550

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.