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Clinical Trials/NCT05984914
NCT05984914
Recruiting
Not Applicable

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

Maria Charalampopoulou1 site in 1 country60 target enrollmentJanuary 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Maria Charalampopoulou
Enrollment
60
Locations
1
Primary Endpoint
Psychological I
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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, hair cortisol collection, and blood material extraction.

Understanding the role of stress management in breast cancer may lead to improved patient outcomes and survival rates.

Detailed Description

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, collecting hair cortisol samples, and extracting genetic (DNA) material to study the telomere length of T-cells from peripheral blood. 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.

Registry
clinicaltrials.gov
Start Date
January 4, 2021
End Date
January 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Maria Charalampopoulou
Responsible Party
Sponsor Investigator
Principal Investigator

Maria Charalampopoulou

PhD candidate

National and Kapodistrian University of Athens

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of primary breast cancer
  • Completion of anticancer therapy (except for hormonal therapy)

Exclusion Criteria

  • Psychiatric diagnosis and treatment
  • Metastasis
  • Previous participation in any stress management and health promotion study
  • Inability to read or write in Greek

Outcomes

Primary Outcomes

Psychological I

Time Frame: 9 weeks after the 1st session

Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score)

Psychological II

Time Frame: 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

Time Frame: 9 weeks after the 1st session

Telomere length (measured in mean T/S)

Physical II

Time Frame: 9 weeks after the 1st session

Hair cortisol levels (measured in pg/mg )

Secondary Outcomes

  • Physical III(9 weeks after the 1st session)
  • Psychological III(9 weeks after the 1st session)

Study Sites (1)

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