Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

Thoracic Cancer Clinical Trial

— PGHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342284
• Other study ID #: NYPC ERC# 2021-030
• Status: Recruiting
• Start date: March 22, 2024
• Est. completion date: March 21, 2031

Study information

• Verified date: March 2024
• Source: The New York Proton Center
• Contact: Nitin Ohri, MD
• Phone: 718-405-8550
• Email: nitin.ohri[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 21, 2031
• Est. primary completion date: March 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Cancer

Intervention

Radiation:
• Proton Beam Radiation with or without concurrent chemotherapy
Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy

Locations

Country	Name	City	State
United States	New York Proton Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Proton Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses.	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.	5 Years
Primary	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.	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.	4-5 Weeks
Secondary	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.	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.	4-5 Weeks