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NCT Number: NCT06342284

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.

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Key information

Conditions

Thoracic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

New York Proton Center

New York, 10035, United States

Location status: Recruiting

Location contact

Alexandra Hanlon, PhD

SUB_INVESTIGATOR

Annemarie Shepherd, MD

SUB_INVESTIGATOR

Charles Simone, MD

SUB_INVESTIGATOR

Nitin Ohri, MD

PRINCIPAL_INVESTIGATOR

Ryan Holder, BS

CONTACT

[email protected]

646-968-9055

Stanislav Lazarev, MD

SUB_INVESTIGATOR

Thomas Mistretta, MS

CONTACT

[email protected]

646-568-5675

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.

Primary Objective

  • To demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer.

Secondary Objective • To demonstrate the face validity of physical activity and vital sign data collected during proton beam radiotherapy for lung cancer.

Exploratory Objective

  • To explore associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proton Beam Radiation with or without concurrent chemotherapy

Radiation

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

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.

    Time frame: 4-5 Weeks

    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.

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.

    Time frame: 4-5 Weeks

    Face validity will be evaluated by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics (mean, standard deviation, median, range) and visually using histograms and boxplots. Additionally, the proportion of reported measures outside of the expected range based on subjects' medical conditions and data obtained during clinic visits (i.e., non-physiologic outliers) will be estimated by the study team. Data elements will be deemed to have face validity if less than 5% of the collected values fall outside the expected range.

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.

    Time frame: 5 Years

    Inferential statistical analyses carried out in support of this objective will be exploratory, recognizing the feasibility nature of the study, the associated lack of statistical power, and that these analyses are intended to estimate effect sizes to inform future studies.

Study contacts

Contact information is provided by the study sponsor or research team.

Nitin Ohri, MD

CONTACT

[email protected]

718-405-8550

Ryan Holder, BS

CONTACT

[email protected]

646-968-9055

Sponsors and collaborators

Lead sponsor

The New York Proton Center

Other

Registry information

Official study title

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

Acronym: PGHD

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Apr 2, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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