Psychological and Biological Outcomes in Breast Cancer Patients After Pythagorean Self-Awareness Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Psychological I
研究概览
简要总结
Intense stress has harmful effects on the body, contributing to various disorders. Breast cancer patients experience a build-up of stress due to their diagnosis and treatments. Stress can cause epigenetic changes in a cellular level (such as accelerated increase in biological age) that may negatively affect oncological treatments.
This study aims to investigate the effect of stress management, specifically the Pythagorean Self-Awareness Intervention, on telomere length in T-leukocytes of breast cancer patients after completing all treatments except hormonal therapy. The study involves self-referred questionnaires and blood material extraction.
Understanding the role of stress management in breast cancer may lead to improved patient outcomes and survival rates.
详细描述
Distress can have serious effects on the human body and is known to contribute to various disorders, including cardiovascular diseases. In the case of breast cancer, patients often experience a build-up of stressful events throughout their journey with the disease, such as diagnosis, surgery, chemotherapy, radiotherapy, survival, and dealing with side effects of anticancer therapy.
Many studies have shown that psychological stress is closely related to increased cortisol levels in the body. This stress may lead to epigenetic changes in telomere length, the action of telomerase, the function of T-leukocytes, and the response of pro-inflammatory cytokines, all of which play significant roles in the treatment of oncological patients.
Considering these factors, managing stress becomes crucial, as it can not only indirectly affect the disease's outcome but also impact survival. This scientific protocol aims to investigate the impact of a holistic stress management program on the telomere length of T-leukocytes in the peripheral blood of women diagnosed with breast cancer.
The stress management technique to be employed is the Pythagorean Self-Awareness Intervention, which will be administered only after completing all cancer treatments, except for hormonal therapy. The methods that will be followed include distributing self-referred questionnaires to assess stress and lifestyle and extracting genetic (DNA) material to study the telomere length of T-cells from peripheral blood and Total Oxidative Stress status.
By studying the impact of stress and its management on telomere length in breast cancer patients, this study aims to contribute to a better understanding of how stress affects health outcomes and potentially provide insights into improving patient care.
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 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary breast cancer
- •Completion of anticancer therapy (except for hormonal therapy)
排除标准
- •Psychiatric diagnosis and treatment
- •Metastasis
- •Previous participation in any stress management and health promotion study
- •Inability to read or write in Greek
研究组 & 干预措施
PSAI group
Participants are enrolled in the Pythagorean Self-Awareness Intervention (PSAI) where they receive weekly group sessions of 120 min for 6 weeks and they receive information about stress and lifestyle modifications and they are also instructed to practice the PSAI at bedtime and in the morning, every day, at home.
干预措施: PSAI (Behavioral)
Control group
One day seminar where they receive information about stress and lifestyle modifications
干预措施: One day seminar (Behavioral)
结局指标
主要结局
Psychological I
时间窗: 9 weeks after the 1st session
Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)
Psychological II
时间窗: 9 weeks after the 1st session
Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores)
Physical I
时间窗: 9 weeks after the 1st session
Telomere length (measured in mean T/S)
Physical II
时间窗: 9 weeks after the 1st session
Total Oxidant Status. Measured in blood serum. Expected outcome: decrease.
Physical III
时间窗: 9 weeks after the 1st session
Body Composition Analysis (assessed by bio-impedance device)
次要结局
- Physical III(9 weeks after the 1st session)
- Lifestyle parameter I(9 weeks after the 1st session)
- Lifestyle parameter II(9 weeks after the 1st session)
- Lifestyle parameter III(9 weeks after the 1st session)
- Lifestyle parameter IV(9 weeks after the 1st session)
- Psychological III(9 weeks after the 1st session)
- Psychological I(9 weeks after the 1st session)
- Psychological II(9 weeks after the 1st session)
研究者
Maria Charalampopoulou
PhD candidate
National and Kapodistrian University of Athens
