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临床试验/NCT05984914
NCT05984914已完成不适用

Psychological and Biological Outcomes in Breast Cancer Patients After Pythagorean Self-Awareness Intervention.

Maria Charalampopoulou2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年6月4日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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

发起方
Maria Charalampopoulou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maria Charalampopoulou

PhD candidate

National and Kapodistrian University of Athens

研究点 (2)

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