Collecting health data from lung cancer patients during proton therapy
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study
This study is trying to see if collecting health information from lung cancer patients using devices like smartwatches during their proton therapy can help understand their treatment experience better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The New York Proton Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06342284 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with non-small cell or small cell lung cancer planning to undergo curative proton beam radiotherapy.
Not a fit: Patients currently receiving treatment for another cancer or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of patient experiences and health metrics during lung cancer treatment, potentially leading to improved care strategies.
How similar studies have performed: While the use of wearable devices in cancer care is gaining traction, this specific approach to collecting patient-generated health data during proton therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.