Feasibility Study of Meditation, Cognitive Function, and Quality of Life in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)
研究概览
简要总结
The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied.
详细描述
Screening Tests:
During the "screening" visit, you will be asked 4 questions about your memory and concentration abilities. Based on how you score on this screening questionnaire, you may not be eligible to participate in the study even if you have already signed the informed consent form.
If you are found to be eligible for the study based on the screening questionnaire, you will complete some tests during the screening visit to check your memory and concentration. For example, you will be asked to remember a list of words and then be asked to recall them later. You will also complete questionnaires asking about your mood, quality of life, and other things like sleep, nervousness, and your experience with cancer. All together, the tests and questionnaires should take about 90 minutes to complete.
Study Groups:
You will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. People in Group 1 will take part in a Tibetan meditation program. People in Group 2 will be placed on a waiting list. They may participate in the meditation program 3 months after being enrolled in the study (when Group 1 has finished the follow-up visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment.
- •Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog.
- •Women must be 18 years or older.
- •Women must be able to read, write and speak English.
- •Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs)
- •Willing to come to MDACC for the meditation sessions and assessment sessions.
- •Women must be within 2 hours driving distance of MDACC.
排除标准
- •Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- •Women with metastatic disease to the brain or any past neurologic injury.
- •Women with a Mini-Mental State Examination score of 23 or below.
- •Women with recurrent cancer
结局指标
主要结局
Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)
时间窗: 2 Years
Women's Reported Satisfaction with Tibetan Meditation intervention
时间窗: 2 Years
次要结局
未报告次要终点