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Идёт набор NCT06342284

Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer

— Наблюдательное Thoracic Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Proton Beam Radiation with or without concurrent chemotherapy.
Кому может быть актуально
Состояния в реестре: Thoracic Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • 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. [Срок оценки: 4-5 Weeks]
Вторичные конечные точки (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. [Срок оценки: 4-5 Weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • New York Proton Center — New York

Идентификаторы

NCT: NCT06342284 · NYPC ERC# 2021-030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗