NCT06342284 Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
| NCT ID | NCT06342284 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The New York Proton Center |
| Condition | Thoracic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-03-22 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-03-22 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
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
Contact & Investigator
Nitin Ohri, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT06342284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06342284 currently recruiting?
Yes, NCT06342284 is actively recruiting participants. Contact the research team at nitin.ohri@einsteinmed.edu for enrollment information.
Where is the NCT06342284 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06342284 clinical trial?
NCT06342284 is sponsored by The New York Proton Center. The principal investigator is Nitin Ohri, MD at Montefiore Medical Center. The trial plans to enroll 40 participants.
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