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临床试验/NCT07234799
NCT07234799暂停不适用

Feasibility Testing of a Dyadic Exercise Program for Patients Undergoing Thoracic Radiotherapy and Their Family Caregivers

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
40
试验地点
1
主要终点
Quality of Life Questionnaire

研究概览

简要总结

The goal of this study is to examine the feasibility and acceptability of an exercise intervention for patients undergoing thoracic radiation and their family caregivers.

详细描述

Primary Objectives:

  1. Examine the feasibility and acceptability of an exercise program
  2. Examine an initial sign for intervention efficacy by examining pre/post-test scores for patients' objective physical function and patient and caregiver subjective physical and mental quality of life.

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 and able (self-identified) to participate in the exercise program
  • •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

排除标准

  • •A patient who meets the following criteria will be excluded from participating in this study:
  • •Cognitive deficits noted in the medical records and/or cognitive deficits that would impede the completion of self-report instruments as deemed by the patient's attending radiation oncologist.
  • •Experiences contraindications to exercise as determined by the clinical team
  • •Regularly (self-defined) participates in an exercise program in the year prior to diagnosis
  • •A patient and caregiver who is pregnant (medical notes and/or self-identified, respectively) will be excluded.

研究组 & 干预措施

Exercise Protocol

Experimental

The protocol will be comprised of up to 15 exercise sessions over the course of participants' 5-6 weeks radiation treatment period with each session lasting up to 60 minutes. Exercise sessions are a combination of resistance, aerobic, and flexibility training using bodyweight and/or elastic bands for resistance.

干预措施: Exercise (Other)

结局指标

主要结局

Quality of Life Questionnaire

时间窗: Through study completion; an average of 1 year

Patients and caregivers will complete the Medical Outcomes. Study 36-item short-form survey (SF-36) assessing 8 distinct domains of QOL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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