An Early Stress-Reduction Intervention in Patients With Newly Diagnosed Breast Cancer: A Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3
研究概览
简要总结
The goal of this research study is to learn if starting a stress-reduction program before treatment can affect your stress, mood, and physical symptoms during and after treatment for cancer.
This is an investigational study.
Up to 140 participants will be enrolled in this study. All participants will be recruited at MD Anderson.
详细描述
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being in either group:
- If you are in Group 1, you will be asked to do daily mind-body exercises for 14 days, beginning before you start receiving chemotherapy. The exercises are short, about 10 minutes per day. The exercises are presented on an online application ("app") that runs on your personal electronic device (such as a mobile phone or tablet). You will be required to install the application on your personal device and to create an account. The study staff will tell you how to perform the exercises, install the application, and create an account. During the 14 days, you will receive automated daily reminders to do the exercises. After you have finished the 14 days of mind-body exercises, you may continue to use the application free of charge for the remainder of the year. After the first year, if you want to keep using the application, you will have to pay for it.
- If you are in Group 2, you will not perform the mind-body exercises. You will be offered one year of free access to the application described above at your last study visit.
Study Visits - All Participants:
Before you start chemotherapy:
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 are followed by the Department of Breast Medical Oncology and are recommended for neoadjuvant chemotherapy, any regimen. If chemotherapy is received in an outside facility, patients are eligible if they are scheduled to return to MD Anderson after completion of chemotherapy.
- •Patients = or > 18 years old
- •Patients who speak English
- •Patients who are willing and able to review, understand, and provide written consent
- •Patients who agree to comply with all study procedures
- •Patients who have access to a mobile phone, tablet, or personal computer, that supports the Headspace application
排除标准
- •Patients with a documented diagnosis of a formal thought disorder (e.g., schizophrenia)
- •Patients who are currently or have been in the past three months actively engaged in meditation-related exercises for at least one hour a week
- •Patients who are currently receiving psychotherapy
- •Patients with pre-existing diagnosis of an inflammatory autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, or multiple sclerosis
- •Patients who are currently taking adrenergic receptor antagonist (e.g., propranolol) or corticosteroids (e.g., dexamethasone, methylprednisolone)
研究组 & 干预措施
Standard of Care
Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
干预措施: Questionnaires (Behavioral)
Mind-Body Exercises
Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are presented on an online application ("app") that runs on participant's personal electronic device (such as a mobile phone or tablet).
Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
干预措施: Mind-Body Exercises (Behavioral)
Mind-Body Exercises
Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are presented on an online application ("app") that runs on participant's personal electronic device (such as a mobile phone or tablet).
Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
干预措施: Questionnaires (Behavioral)
结局指标
主要结局
Effect of the Stress-Reduction Intervention on Changes in Patient-Reported Outcomes From T0 to T2 and T3
时间窗: Baseline up to 6 months after chemotherapy
For the primary objective, changes from T0 to T2 and T3 in neurotoxic somatic symptoms analyzed with multilevel models, in which changes over time are estimated simultaneously across groups.
次要结局
- Changes in Inflammatory Markers(Baseline up to 6 months after chemotherapy)
- Associations of patient-reported stress and neuroendocrine biomarkers(Baseline up to 6 months after chemotherapy)
- Associations of patient-reported neurotoxic somatic and depressive symptoms with inflammatory biomarkers and mitochondrial functioning during and after chemotherapy.(Baseline up to 6 months after chemotherapy)
- Changes in Mitochondrial Function(Baseline up to 6 months after chemotherapy)
- Determine the relation between motivational effort expenditure and the neurotoxic symptom fatigue.(Baseline up to 6 months after chemotherapy)
- The association between EEfRT outcome and patient-reported stress and personality characteristics assessed with separate GEE models(Baseline up to 6 months after chemotherapy)