Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 135
- 试验地点
- 4
- 主要终点
- Tumor specific fatigue symptomatology
研究概览
简要总结
This research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy.
详细描述
This randomized research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking (MSCW)) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy. The results of both groups are compared with each other and with those of a control group.
The MSCW program combines endurance based physical activity in the form of medically controlled walking, as well as standardized, evidence-based mindfulness exercise elements in a training program.
The participants of both active groups (Walking and MSCW) practice for 12 weeks, once a week for 60 minutes under the guidance of a trainer in a group and 2 additional times (60 minutes each) independently at home.
The purpose of this study is to prevent a sharp decline in quality of life due to fatigue symptoms by participating in the MSCW training program.
A total of 135 participants will be included in the study. All participants are followed for 1 year.
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
- Single (Participant)
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
- •Patients diagnosed with breast cancer who have started antineoplastic therapy (chemotherapy / radiotherapy).
- •Age ≥18 years
- •The patient must be able to perform the study intervention (physically and psychologically).
- •oral and written consent to participate in the study.
排除标准
- •distant metastases
- •Severe mental and / or additional organic illnesses
- •Clinically relevant cardiac arrhythmias or angina pectoris
- •Severe pulmonary disease
- •inadequate walking ability or gait disturbance (including neurological deficits, endoprosthesis supply that lead to gait insecurity)
- •regular meditation practice (several times a week)
- •Planned start of meditation, relaxation, MBSR, yoga, Qi Gong courses over the next 24 weeks.
- •Participation in other intervention studies on walking or meditation
- •Insufficient knowledge of the German language
结局指标
主要结局
Tumor specific fatigue symptomatology
时间窗: Change from baseline to 12, 24 and 52 weeks
Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome
次要结局
- Anxiety and depression(Change from baseline to 12, 24 and 52 weeks)
- Immune defence(Change from baseline to 12, 24 and 52 weeks)
- Mindfulness(Change from baseline to 6, 12, 24 and 52 weeks)
- Anxiety(Change from baseline to 12, 24 and 52 weeks)
- Alpha-Amylase(Change from baseline to 12, 24 and 52 weeks)
- cardiac function parameters(Change from baseline to 12, 24 and 52 weeks)
- Self-Compassion(Change from baseline to 6, 12, 24 and 52 weeks)
- Stress(Change from baseline to 12, 24 and 52 weeks)
- Heart rate variability(Change from baseline to 12, 24 and 52 weeks)
- Disease-specific quality of life(Change from baseline to 12, 24 and 52 weeks)
研究者
Yves Steininger
Principal Investigator
Charite University, Berlin, Germany