Dyadic Yoga Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers: The Testing of a Mobile Application Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety and Adverse Events (AEs)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Experiences cognitive deficits that would impede the completion of self-report instruments as deemed by their attending oncologist per medical notes and/or patient not being oriented to time, place and person.
- •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.
研究组 & 干预措施
Thinking Out Loud Group
Participants will be identified using the electronic clinic appointment systems for the thoracic radiation clinic and prescreened for their date of birth (i.e. minimum 18 years old), disease, treatment schedule, ECOG and other criteria (e.g., exercise intolerance, cognitive deficits).
干预措施: Thinking out Loud Session (Behavioral)
结局指标
主要结局
Safety and Adverse Events (AEs)
时间窗: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点