Clinical trial NCT06342284: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
Official title: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Cancer
Lead sponsor: The New York Proton Center
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 17 years old that will be receiving proton beam thoracic radiotherapy with curative intent for lung cancer.

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: 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.
timeFrame: 4-5 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 4-5 Weeks
Other outcomes:
measure: Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses.
timeFrame: 5 Years
Locations:
city: New York
country: United States
facility: New York Proton Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Nitin Ohri, MD
role: PRINCIPAL_INVESTIGATOR
References: