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Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Subjects will complete a short satisfaction survey at the end of the study period."
  • "Exploratory Objective • To explore associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

NY