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临床试验/NCT02360904
NCT02360904已完成不适用

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
change in quality of life

研究概览

简要总结

The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
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

  • Age>18 years
  • History of stage I-III breast cancer
  • Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers
  • Eastern Cooperative Oncology Group Performance status of <3
  • Ability to understand English

排除标准

  • Planning to start yoga on their own within the next 12 weeks
  • Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
  • Severe chronic obstructive pulmonary disease
  • Class III or IV heart failure
  • Child C cirrhosis
  • End-Stage renal disease
  • Exclusion Criteria:
  • Planning to start yoga on their own within the next 12 weeks
  • Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
  • Severe chronic obstructive pulmonary disease
  • Class III or IV heart failure
  • Child C cirrhosis
  • End-Stage renal disease

结局指标

主要结局

change in quality of life

时间窗: 12 weeks

to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga immediately and those start yoga 3 months later.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Theresa Shao

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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