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| Name | Class |
|---|---|
| Hippocration General Hospital | OTHER |
| Saint Savvas Anticancer Hospital | OTHER |
| Hellenic Anticancer Institute | UNKNOWN |
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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 and blood material extraction.
Understanding the role of stress management in breast cancer may lead to improved patient outcomes and survival rates.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Active Comparator | One day seminar where they receive information about stress and lifestyle modifications |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSAI | Behavioral | The 6 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical I | Telomere length (measured in mean T/S) | 9 weeks after the 1st session |
| Physical II | Total Oxidant Status. Measured in blood serum. Expected outcome: decrease. | 9 weeks after the 1st session |
| Physical III | Body Composition Analysis (assessed by bio-impedance device) | 9 weeks after the 1st session |
| 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-depression (measured by Hospital Anxiety Depression Scale, expected decrease in mean scores) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flora Bacopoulou, MD,PhD | Aghia Sofia Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agios Savvas Hospital | Athens | 11522 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19488073 | Background | Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol. 2009 Jul;5(7):374-81. doi: 10.1038/nrendo.2009.106. Epub 2009 Jun 2. | |
| 23941600 | Background | Lin Y, Wang C, Zhong Y, Huang X, Peng L, Shan G, Wang K, Sun Q. Striking life events associated with primary breast cancer susceptibility in women: a meta-analysis study. J Exp Clin Cancer Res. 2013 Aug 13;32(1):53. doi: 10.1186/1756-9966-32-53. |
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All IPD that underlie results in a publication
After publication of the study
On request
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| One day seminar | Behavioral | 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. |
|
| 9 weeks after the 1st session |
| Psychological III | Concerns about cancer recurrence (measured by Concerns About Recurrence Scale, expected decrease in means score) | 9 weeks after the 1st session |
| Lifestyle parameter I | Adherence to Mediterrenean Diet (measured by MedDiet, expected increase in means score) | 9 weeks after the 1st session |
| Lifestyle parameter II | Adherence to a Healthy Lifestyle (measured by Healthy Lifestyle and Personal Control Questionnaire, expected increase in means score) | 9 weeks after the 1st session |
| Lifestyle parameter III | Sleep quality (measured by Pittsburgh Sleep Quality Index, expected decrease in means score) | 9 weeks after the 1st session |
| Lifestyle parameter IV | Physical activity (measured by International Physical Activity Questionnaire -7, expected increase in METs/week) | 9 weeks after the 1st session |
| 17785865 | Background | Damjanovic AK, Yang Y, Glaser R, Kiecolt-Glaser JK, Nguyen H, Laskowski B, Zou Y, Beversdorf DQ, Weng NP. Accelerated telomere erosion is associated with a declining immune function of caregivers of Alzheimer's disease patients. J Immunol. 2007 Sep 15;179(6):4249-54. doi: 10.4049/jimmunol.179.6.4249. |
| 31901782 | Background | Charalampopoulou M, Bacopoulou F, Syrigos KN, Filopoulos E, Chrousos GP, Darviri C. The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial. Breast. 2020 Feb;49:210-218. doi: 10.1016/j.breast.2019.12.012. Epub 2019 Dec 20. |
| 25367403 | Background | Carlson LE, Beattie TL, Giese-Davis J, Faris P, Tamagawa R, Fick LJ, Degelman ES, Speca M. Mindfulness-based cancer recovery and supportive-expressive therapy maintain telomere length relative to controls in distressed breast cancer survivors. Cancer. 2015 Feb 1;121(3):476-84. doi: 10.1002/cncr.29063. Epub 2014 Nov 3. |
| D017437 |
| Skin and Connective Tissue Diseases |