Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

NCT06342284 | Recruiting

• 1 other identifier: NYPC ERC# 2021-030
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  4-5 Weeks

Other Outcomes (1)

• Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses.

  5 Years

Interventions

Proton Beam Radiation with or without concurrent chemotherapy RADIATION

Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over the age of 17 years old that will be receiving proton beam thoracic radiotherapy with curative intent for lung cancer.

You may qualify if:

• 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

You may not qualify if:

• Ongoing treatment for another cancer that is expected to affect the toxicity profile of thoracic radiotherapy

Sponsors & Collaborators

• The New York Proton Center: lead

Study Sites (1)

New York Proton Center

New York, New York, 10035, United States

RECRUITING

Study Officials

• Nitin Ohri, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Ohri, MD

CONTACT

718-405-8550; nitin.ohri@einsteinmed.edu

Ryan Holder, BS

CONTACT

646-968-9055; rholder@nyproton.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 2, 2024
• Study Start: March 22, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 21, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)