跳至主要内容
临床试验/NCT01952860
NCT01952860终止不适用

A Feasibility Study of Hatha Yoga in Couples Coping With Lung Cancer

M.D. Anderson Cancer Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
2
主要终点
Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by attendance

研究概览

简要总结

The goal of this research study is to learn the opinion of patients and their caregiving about a couple-based Hatha Yoga program during treatment for cancer. Researchers also want to learn the effect of this program on lung function, distress, and quality of life.

详细描述

If participant agrees to take part, participant's medical history and demographic information (such as age, sex, and race) will be recorded. By signing this consent, participant also agrees that participant's caregiving partner will be approached to take part in this study.

Questionnaires:

Participant will complete about 10 questionnaires before participant's first radiation treatment and again after participant completes participant's treatment schedule (usually 6 weeks later). The questionnaires ask about participant's health, any symptoms participant may be having, participant's mood, participant's level of fatigue, participant's sleeping habits, participant's relationship, and participant's quality of life. It should take about 45 minutes to complete these questionnaires.

Participant will complete about 5 questionnaires again halfway through participant's radiation treatment schedule. These questionnaires ask about participant's quality of life. These should take about 20 minutes to complete.

During each week of radiation therapy, participant will also complete a questionnaire asking participant's feelings about the Hatha Yoga sessions. Participant will be asked to list what participant liked or disliked, what participant found most and least useful, and how participant would rate the instructor. Participant will also be asked about how often participant practices outside of class and if participant thinks they are benefitting from the Hatha Yoga program. It should take about 5 minutes to answer this questionnaire. Participant's answers to the questions will not be shared with participant's caregiving partner.

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

入选标准

  • Patients with non-small cell lung cancer (NSCLC) stages I through IIIB who are going to receive at least 5 weeks of thoracic radiation therapy with or without chemotherapy undergoing daily radiation treatment in the Department of Radiation Oncology at M. D. Anderson Cancer Center (MDACC) and an eligible and consenting caregiving partner.
  • Patients and caregiving partners must both be at least 18 years old.
  • Participants have a study eligible and consenting caregiving partner spouse or significant other (e.g, romantic partner). (i.e. spouse, romantic/domestic partners, significant others).
  • Patients and caregiving partners should be able to read, write, and speak English.

排除标准

  • Patients who are not oriented to time, place, and person.
  • Patients who have practiced Tibetan or Hatha yoga in the year prior to diagnosis on a regular basis.
  • Lung cancer patients with a life expectancy of less than 6 months per attending physician estimation.
  • Lung cancer patients with the attending physician-rated Eastern Cooperative Oncology Group (ECOG) performance status score of greater than 2 at the time of radiotherapy initiation.

结局指标

主要结局

Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by attendance

时间窗: 6 weeks

If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible.

Feasibility of Yoga Program in Lung Cancer Participants Receiving Radiation determined by questionnaire responses.

时间窗: 6 weeks

If over 50% of eligible participants participate and at least 80% of the participants are evaluable for follow-up (completing at least one follow-up assessment in the middle of radiotherapy and during the last week of radiotherapy), the study will be deemed feasible. European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer-specific Quality of Life Questionnaire (QLQ-LC13) used for the follow-up assessment.

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 (2)

Loading locations...

相似试验