Stress Management and Biological Age in Breast Cancer Patients.RCT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Breast Cancer, Telomere Length, Mean Leukocyte

Intervention / Treatment
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* Behavioral: PSAI
* Behavioral: One day seminar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSAI group<br>Participants are enrolled in the Pythagorean Self-Awareness Intervention (PSAI) where they receive weekly group sessions of 120 min for 8 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. | Behavioral: PSAI<br>* The 8 sessions included biofeedback training in diaphragmatic breathing, information about distress, its symptoms, ways to manage stress through lifestyle modifications (physical activity, principals of Mediterranean diet without alcohol consumption, sleep hygiene, diaphragmatic breathing, conflict avoidance) & instructions for lymphedema prevention, introduction to the Pythagorean Self-Awareness Intervention, instructions for the implementation of the technique, analysis of the Golden Verses,and their connection with lifestyle medicine as well as active involvement of the participants with group conversation and sharing of experiences.<br>* Other names: Pythagorean Self-Awareness Intervention;|
| Active Comparator: Control group<br>One day seminar where they receive information about stress and lifestyle modifications | Behavioral: One day seminar<br>* The one day seminar included biofeedback training in diaphragmatic breathing, information about distress, its symptoms, ways to manage stress through lifestyle modifications (physical activity, principals of Mediterranean diet without alcohol consumption, sleep hygiene, diaphragmatic breathing, conflict avoidance) & instructions for lymphedema prevention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological I | Perceived stress (measured by Perceived Stress Scale-14, expected decrease in mean score) | 9 weeks after the 1st session | 
| Psychological II | Symptoms of anxiety-stress-depression (measured by Depression Anxiety Stress Scale-21, expected decrease in mean scores) | 9 weeks after the 1st session | 
| Physical I | Telomere length (measured in mean T/S) | 9 weeks after the 1st session | 
| Physical II | Hair cortisol levels (measured in pg/mg ) | 9 weeks after the 1st session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical III | Body Composition Analysis (measured in kg and %) | 9 weeks after the 1st session | 
| Psychological III | QOL (measured by European Organization for Research and Treatment Questionnaire, expected increase in means score) | 9 weeks after the 1st session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Breast Cancer, Lifestyle, Stress management, Telomeres, Biological age, PSAI