RECRUITING

Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study

Quick Facts

Study Start:2024-03-22
Study Completion:2031-03-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06342284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Plan for fractionated (≥15 treatments) proton beam thoracic radiotherapy with curative intent for lung cancer
  2. * Non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC) histology is permitted.
  3. * Concurrent chemotherapy is permitted but not required..
  4. * Previous thoracic radiotherapy is allowed.
  5. * Ability to complete study surveys in English or Spanish
  6. * Age \>/= 18
  7. * Concurrent enrollment on other trials is permitted
  8. * 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
  9. * All patients must sign study-specific informed consent prior to study entry
  1. * Ongoing treatment for another cancer that is expected to affect the toxicity profile of thoracic radiotherapy
  2. * 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

Contacts and Locations

Study Contact

Nitin Ohri, MD
CONTACT
718-405-8550
nitin.ohri@einsteinmed.edu
Ryan Holder, BS
CONTACT
646-968-9055
rholder@nyproton.com

Principal Investigator

Nitin Ohri, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

New York Proton Center
New York, New York, 10035
United States

Collaborators and Investigators

Sponsor: The New York Proton Center

  • Nitin Ohri, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

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

Study Start Date2024-03-22
Study Completion Date2031-03-21

Study Record Updates

Study Start Date2024-03-22
Study Completion Date2031-03-21

Terms related to this study

Additional Relevant MeSH Terms

  • Thoracic Cancer