Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
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
🗓️ Study Start (Actual) 22 March 2024
🗓️ Primary Completion (Estimated) 21 March 2026
✅ Study Completion (Estimated) 21 March 2031
👥 Enrollment (Estimated) 40
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 March 2024
  • First Submitted that Met QC Criteria 25 March 2024
  • First Posted 2 April 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 25 March 2024
  • Last Update Posted 2 April 2024
  • Last Verified March 2024