Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 681
- 试验地点
- 2
- 主要终点
- Efficacy of Relaxation Program
研究概览
简要总结
The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs.
This is an investigational study. The relaxation programs are being compared for research purposes only.
An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires.
Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.
详细描述
During the first visit, you will fill out questionnaires that ask about your sleeping habits, how you have been feeling, and the general quality of your life. This should take about 60-80 minutes.
Every day for the next 7 days, you will fill out a diary about your sleep. You will also wear an "actigraph" wrist watch 24 hours a day for these 7 days. The watch will collect data about your physical activity and sleeping habits.
You will also have an electrocardiogram (ECG - a test to measure the electrical activity of your heart) which will last about 10 minutes.
Study Groups:
After your first visit, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage 0 - III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only).
- •18 years of age or older (patient and spouse/partner).
- •Able to read, write, and speak English or Spanish (patient and spouse/partner).
排除标准
- •Patients who have any major psychiatric diagnoses (e.g., schizophrenia, bipolar disorder).
- •Patients who have not undergone any surgical treatment for their cancer.
- •Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
- •Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice.
结局指标
主要结局
Efficacy of Relaxation Program
时间窗: Prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy
Effectiveness of 6-week relaxation intervention evaluated by physical component scale scores during and after treatment, defined as Medical Outcomes Study 36-item short-form survey (SF-36).
次要结局
未报告次要终点