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Идёт набор NCT06919874

Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery

Без фазы С лечением Non-Small Cell Lung 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: Thinking out Loud Session.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung 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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Обзор

The goal of the trial is to test the usability, feasibility and acceptability of an unsupervised, appbased yoga program for participants undergoing thoracic RT and their caregivers.

Подробное описание

Primary Objective:

The Investigators propose to test the usability, feasibility and acceptability of an unsupervised, app-basedyoga program for patients undergoing thoracic RT and their caregivers. The Investigators specific aims will be carried out in two parts:

Part 1:

• The Investigators will perform the initial usability testing of the working prototypes of both iOS and Android versions to determine whether users can complete the required tasks successfully and independently and to identify problems with navigation and functioning.

The Investigators primary objective is to:

Aim 1: Finalize the working prototype of the yoga app using the feedback of 10 participants-caregiver dyads (mixed-methods study).

Part 2:

• The Investigators will measure feasibility (e.g., consent and retention rates, adherence), usability of the app, and acceptability of the app-based program in 20 newly recruited participants-caregiver dyads. As an exploratory outcome, the investigators include pre- and post-intervention assessments of objective physical function and self-reported QOL. The Investigators will also complete semi-structured interviews to collect qualitative data on participants' evaluation of the mobile app and their experience in participating in this research.

Specific aims are:

Aim 1: Examine the feasibility, usability, and acceptability of an app-based yoga program in 20 patient-caregiver dyads (single-arm trial).

Aim 2: Understand the trial participants' experiences with the mobile app delivery including suggestions for improvement using qualitative methods.

Вмешательства

  • Поведенческое Thinking out Loud Session
    Participants will complete one thinking out loud session (approx. 60 minutes). The session will be led by a yoga therapist (see below) either in person at the hospital or via Zoom. Individual patients, caregivers or patient-caregiver dyads will attend the session. Each participant will need to either bring their own device or will use an institutional loaner device if no personal device is available. During the session, participants will be asked to download the app from the device appropriate a

Первичные конечные точки

  • Safety and Adverse Events (AEs) [Срок оценки: Through study completion; an average of 1 year.]

Критерии участия

Критерии включения

  • Be diagnosed with a non-small cell lung cancer or esophageal cancer and going to receive at least 24 fractions thoracic RT
  • Have an ECOG performance status of <2
  • Have a family caregiver (e.g., spouse, sibling, adult child) willing to participate

Both patient and caregiver must meet all the following criteria:

  • Be >18 years old
  • Be able to read and speak English
  • Be able to provide informed consent
  • Have regular (self-defined) access to Wi-Fi/High speed internet access

Критерии исключения

  • Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist
  • Experiences contraindications to exercise as determined by the clinical team
  • Regularly (self-defined) participants in a yoga program in the year prior to diagnosis

Participants who participated in part 1 are ineligible to participate in part 2 of this protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • The University of Texas M. D. Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06919874 · 2025-0128 · NCI-2025-02119

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗