Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer (PGHD)

The New York Proton Center

Status: Enrolling

Conditions: Thoracic Cancer

Treatments: Radiation: Proton Beam Radiation with or without concurrent chemotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06342284

NYPC ERC# 2021-030

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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