Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proton Beam Radiation with or without concurrent chemotherapy.
- Who it may be relevant to
- Registry conditions: Thoracic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer: A Pilot Study
Overview
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.
Interventions
- Radiation Proton Beam Radiation with or without concurrent chemotherapy
Curative-intent fractionated proton beam thoracic radiotherapy, with or without concurrent chemotherapy
Primary outcome measures
- 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]
Secondary outcome measures (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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- New York Proton Center — New York
Identifiers
NCT: NCT06342284 · NYPC ERC# 2021-030